THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net


S U M M A R Y


DIARY: July 8, 2008 06:30 AM Tuesday; Rod Welch

Millie at Kaiser for Power Port surgery to support tests and treatments.

1...Summary/Objective
2...Power Port Surgery Admission ID Cannot Implant on Primary Cancer Site
3...Patient History Current Medications Lost in Kaiser's Computer
4...IV Blood Draw and Anesthesia Local Anesthetic Avoids Pain Right Arm
5...Local Anesthetic Avoids Pain Right Arm IV Blood Draw and Anesthesia
6...Anesthesia and Blood Draw IV Right Arm Accomplished Minimal Discomfort
7...Power Port Surgery Replace Port Catheter Right Side
8...Surgery Power Port Implant Right Side Remove Replace Port Catheter
9...Annoying Complex Case Management Accuracy Many Details Stressful
10...Surgery Successful Huber Needle Implanted for Treatment at UCSF
11...Huber Needle Implanted for Treatment at UCSF Surgery Successful
12...Recovery Post Surgery Blood Draw Test Power Port Patient Impressions
13...Coumadin INR 1.1 Reflects Pause Treatment 5 Days Prior to Surgery
14...Laboratory Blood Test Results Problems Occurred on Some Tests
15...CA 15-3 141 Cancer Marker Rises Highest Results Possibly Incorrect
16...Cancer Marker Alarming Increase Sample Hemolyzed Results May Be Affected
17...Discharge Power Port Packet and Vicodin Medication for Pain
18...Vicodin Pain Medication Prescribed for Home Care after Discharge
19...Pain Surgery Recovery Home Care Vicodin Prescribed after Discharge
20...Recovery Same Day at Home Power Port Surgery
21...Coumadin Treatment Plan Increase INR Reduce Risks Blood Clots PE
22...INR Low Treatment Plan Reduce Blood Clot Risk Pulmonary Embolism
23...Pulmonary Embolism Case Management Treatment Plan Avoid Blood Clots
24...Patient Cannot Rest Post Surgery Hyper Active
25...Bleeding Cut Finger Blood Clots Normally with Low INR
26...Sleep Difficult Stress Anxiety Surgery Power Outage Cut Finger
27...Vicodin Medication Relieves Mild Pain Surgery Trauma
28...Pain Mild Surgery Trauma Relieved by Vicodin Medication
29...Power Port Certificate Tested Successfully
30...Xray Test Report Favorable Findings Power Port Catheter
31...Documentation Power Port Packet
32...Power Port Packet Documentation
........Identification Card for Power Port with Lot #
........Documentation for Power Port
........Power Port
........Instructions for Use
........CT Contrast Enhanced Computer Tompgraphy Information
33...Trained Clinician Evaluate Patient Health Suitable Injection Power Port
........Signs of Pinch-off
........Possible Complications
........Implantation Instructions
........Implantation Preparation
........Cut-Down Procedure
........Percutaneous Procedure:
........Peel-Apart Sheath Introducer Instructions
........Catheter Tunneling Procedure
........Connect Catheter to Port
........Position Port and Close Incision Site
........Power Injection Procedure
........Heparin Lock Procedure for Open-Ended Catheters
........Determining Port System Volumes
........................FLUSHING VOLUMES, Open-Ended Catheters
........References
........Further Reading
........Air Guard Valved Introducer
........Power Port
........Patient Guide
........How Your PowerPort* Device Is Used
........IDENTIFICATION
........Identify Yourself!
........Feel the Difference!
........HEPARIN LOCKS
........POWER INJECTION/CECT SCANS
........Common Questions and Answers
........TELL YOUR CLINICIAN
........PATIENT CHECKLIST


..............
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CONTACTS 

SUBJECTS
Surgery Power Port Implant Replace Upgrade Port Catheter Original Wo

1303 -
1303 -    ..
1304 - Summary/Objective
1305 -
130501 - Follow up ref SDS 23 0000. ref SDS 14 0000.
130502 -
130503 - Excellent work today by Doctor Riley-Paull and the surgery team at
130504 - Kaiser in Walnut Creek.  Pre-op coordination was effective
130505 - accomplishing IV for anesthetic with minimum discomfort. ref SDS 0
130506 - ME85  Blood test showed INR 1.1 at safe level for the operation.
130507 - ref SDS 0 MF4K  Surgery was successful removing the port catheter and
130508 - implanting a new Power Port moved slightly from the original location
130509 - on the right upper chest.  Xray test after surgery, ref SDS 0 O67N,
130510 - showed correct configuration of the Power Port. ref SDS 0 UY3I  Tests
130511 - showed blood flows freely in both directions. ref SDS 0 WD9J   Millie
130512 - received a letter from the doctor reporting the Power Port is ready
130513 - for use at Kaiser.  A Huber needle was implanted in the port and with
130514 - stitches for treatment at UCSF this week. ref SDS 0 BF4K  UCSF can
130515 - remove the stitches after treatment on Thursday. ref SDS 0 LI5K
130516 - Millie was released to go home.  Kaiser provided a packet with
130517 - documentation on the Power Port. ref SDS 0 DZ5O  Manufacturer's
130518 - instructions require coordination to verify the Power Port is used
130519 - correctly to perform "Power Injection" of contract medium for the CT
130520 - test scheduled on 080718. ref SDS 0 JE7N  Vicodin was prescribed for
130521 - pain. ref SDS 0 BT8C  Millie was active all day at home.  Kaiser
130522 - revised the treatment plan for Coumadin to increase INR required for
130523 - pulmonary embolism. ref SDS 0 PSPS  Millie cut her finger, and
130524 - initially had trouble getting the blood to clot; eventually the cut
130525 - stopped bleeding. ref SDS 0 BU9X  She was up later than usual watching
130526 - television.  After midnight Millie has mild pain from the surgery.
130527 - She took a Vicodin.  This seemed to help. ref SDS 0 TL4O  She slept
130528 - well through the night.
130530 -                 ..
130531 -                [On 080709 letter to Kaiser primary care physicians
130532 -                requests coordination to verify CT Test department
130533 -                feels comfortable with requirements for Power Port.
130534 -                ref SDS 25 TR4Q
130536 -                 ..
130537 -                [On 080710 Power Port used at UCSF for Millie's
130538 -                treatment; worked perfectly. ref SDS 26 TZ8I
130540 -                 ..
130541 -                [On 080711 Kaiser CT Test Department not prepared to
130542 -                perform test with Power Port, ref SDS 27 JQ49, the
130543 -                Department is preparing a protocol and getting people
130544 -                certified, ref SDS 27 JQ55; Kaiser proposes delaying
130545 -                the test, or using a conventional IV rather than the
130546 -                Power Port provided to prevent damage to Millie's arm.
130547 -                ref SDS 27 JR30
130549 -                 ..
130550 -                [On 080712 Millie notifies primary care physician, and
130551 -                the assistant, Arlette, requesting support for the CT
130552 -                Department to make arrangements in time for the test
130553 -                with the Power Port on 080718. ref SDS 28 KZ5X
130555 -                 ..
130556 -                [On 080715 Arlette received Millie's Power Port Patient
130557 -                Packet for guidance assigning personnel to support the
130558 -                CT test on 080718. ref SDS 29 RB4G
130560 -                 ..
130561 -                [On 080717 Millie separate letter to Kaiser commending
130562 -                the surgeon on successful Power Port surgery and
130563 -                accessing the Power Port for Millie's treatment at UCSF
130564 -                2 days later, and requesting name of anesthesiologist
130565 -                who did great work, ref SDS 31 623X; separate letter
130566 -                because the surgery department does not support
130567 -                communication coordinating with the medical team.
130568 -                ref SDS 31 EF5I
130570 -                 ..
130571 -                [On 090720 1437 ER refused to use Millie's Power Port
130572 -                for injecting contrast medium to perform CT test
130573 -                evaluating Millie's breathing problems caused by
130574 -                radiatoin injury, ref SDS 43 OK95; this caused access
130575 -                to fail with trauma to nurses and the patient's
130576 -                daughter seeing Millie suffer through multiple attempts
130577 -                to get adequate blood flow with conventional IV.
130578 -                ref SDS 43 PQ4V
130580 -                 ..
130581 -                [On 091019 0007 report that nurses in Chemotherapy
130582 -                Infusion Clinic suffered trauma because blood would not
130583 -                flow from Millie's power port, and so used conventional
130584 -                IV which caused severe pain and suffering to Millie;
130585 -                review indicated the Huber needle was only .75" which
130586 -                conflicts with 1" needle needed for adequate tip
130587 -                penetration that enables sufficient blood flow.
130588 -                ref SDS 44 0Z9P
130589 -
130590 -
130591 -
130593 -  ..
1306 -
1307 -
1308 - Progress
1309 -
130901 - Power Port Surgery Admission ID Cannot Implant on Primary Cancer Site
130902 -
130903 - Follow up ref SDS 23 IT77, ref SDS 14 IT77.
130904 -
130905 - Millie checked in at 0630 with "care partner" Lee Mourner, for the
130906 - surgery department.  This complied with the call late yesterday
130907 - changing the time for check in from 1145 to 0630.
130909 -  ..
130910 - Lee said Millie's surgery has been moved up from 0930 to 0900 this
130911 - morning.
130912 -
130914 -  ..
1310 -
1311 -
1312 - 0750
1313 -
131301 - Pamella prepared administrative documents to admit Millie for surgery.
131307 -  ..
131308 - Pamella called and verified that Millie has already paid the $250
131309 - co-payment for Kaiser's work today.
131310 -
131311 -
131312 -
131313 -
1314 -

SUBJECTS
Power Port Surgery Preparation Administrative Documentation Current

3003 -
3004 - 0710
300501 -  ..
300502 - Patient History Current Medications Lost in Kaiser's Computer
300503 -
300504 - Millie was taken into surgery pre-op department.  She changed into a
300505 - patient gown, and layed on the gurney.
300507 -  ..
300508 - The nurse wheeled in a computer next to Millie's gurney.  She asked
300509 - questions discussed yesterday with Doctor Enis, ref SDS 23 IT77, and
300510 - confirmed in Millie's letter to Kaiser for pre-op coordination.
300511 - ref SDS 23 AC59
300516 -  ..
300517 - The nurse could not find current medications listed in Millie's
300518 - Medical Chart on Kaiser's computer.  She asked Millie if she can
300519 - remember all of her medications?  Millie remembered 3 - 4 of the 14
300520 - medications prescribed in the Medical Chart listed for the meeting
300521 - with the primary care physician on 080627. ref SDS 21 7Y6F
300523 -  ..
300524 - Millie cited patient history from the letter to Kaiser yesteday...
300525 -
300526 -        1.  IBC................................ ref SDS 23 4Q5R
300527 -
300528 -            Medications include...
300529 -
300530 -            Cetuximab
300531 -            Carboplatin
300532 -            Neupogen
300533 -            Benedryl
300534 -            Zofran
300535 -            Compazine
300536 -            Ativan
300537 -
300539 -             ..
300540 -        2.  Pulmonary embolism.................. ref SDS 23 4Q5V
300541 -
300542 -            Medications include...
300544 -             ..
300545 -            Coumadin (Warfarin)
300547 -             ..
300548 -        3.  Cellulitis and lymphedema........... ref SDS 23 JP8P
300549 -
300550 -            Medications include...
300552 -             ..
300553 -            Coumadin (Warfarin)
300554 -
300555 -
300556 -
300557 -
3006 -

SUBJECTS
Power Port Surgery Preparation Administrative Documentation Current

4703 -
4704 - 0722
470501 -  ..
470502 - IV Blood Draw and Anesthesia Local Anesthetic Avoids Pain Right Arm
470503 - Local Anesthetic Avoids Pain Right Arm IV Blood Draw and Anesthesia
470504 - Anesthesia and Blood Draw IV Right Arm Accomplished Minimal Discomfort
470505 -
470506 - Doctor Enis came into Millie's cubical and introduced himself.
470508 -  ..
470509 - The doctor thanked Millie for pre-op coordination in her letter
470510 - yesterday on 080707. ref SDS 23 AC59
470512 -  ..
470513 - The doctor explained a change in plans.  Rather than him doing the IV
470514 - for anesthesia, ref SDS 23 JP8P, he has investigated and found another
470515 - doctor who is excellent solving IV problems, like Millie case
470516 - presents.
470517 -
470518 -
470520 -  ..
4706 -
4707 -
4708 - 0742
4709 -
470901 - Another doctor visited Millie to set up the IV for labs and
470902 - anesthesia.
470904 -  ..
470905 - She was very competent and enthusiastic about her work.  The doctor's
470906 - discussion, personality, and approach was reassuring and effective
470907 - working with Millie on an emotional and delicate physicial issue,
470908 - reported on 080425, ref SDS 11 FP6F, and discussed with Doctor Enis
470909 - yesterday on 080707. ref SDS 23 JP8P
470910 -
470911 -                [On 080717 Millie separate letter to Kaiser commending
470912 -                the surgeon on successful Power Port surgery and
470913 -                accessing the Power Port for Millie's treatment at UCSF
470914 -                2 days later, and requesting name of anesthesiologist
470915 -                who did great work, ref SDS 31 623X; separate letter
470916 -                because the surgery department does not support
470917 -                communication coordinating with the medical team.
470918 -                ref SDS 31 EF5I
470920 -  ..
470921 - Millie explained that the IV must be done on her right arm.  The
470922 - doctor commented that veins on top of Millie's right hand look good
470923 - for an IV needle puncture.
470925 -  ..
470926 - Millie explained that previous efforts, most recently on 080425 were
470927 - not successful using that vein. ref SDS 11 FP6F  Millie pointed out
470928 - other locations that were tried and failed, and a location that was
470929 - eventually successful on 080425. ref SDS 11 N076
470931 -  ..
470932 - The doctor will assist the surgeon during the operation today to make
470933 - sure Millie remains comfortable with a local rather than a general
470934 - anesthetic.
470936 -  ..
470937 - Millie asked the doctor to remind the surgeon to include CA 15-3
470938 - cancer marker with blood tests today.
470939 -
470940 -            [...below, CA 15-3 included in scope of labs on blood draw
470941 -            after surgery to test the new port. ref SDS 0 6F4I
470943 -  ..
470944 - The doctor said that the surgeon will likely access the port with a
470945 - Huber needle to draw blood for post-op lab tests.  This will test the
470946 - port required for UCSF treatment on Thursday, as discussed with Doctor
470947 - Enis yesterday, shown in Millie's letter to Kaiser. ref SDS 23 RT9I
470949 -  ..
470950 - The doctor gave Millie a local anesthetic to prevent pain while
470951 - setting up the IV in the right arm.  The IV was actually placed in a
470952 - vein on top of the right hand, mentioned initially by the doctor, per
470953 - above. ref SDS 0 TE4H, and which failed for CT test injection on
470954 - 080425. ref SDS 11 N076  As before, blood flowed very slowly today.
470956 -  ..
470957 - The doctor solved the problem by using a hand pump process to draw
470958 - just enough blood for testing INR needed to verify sufficient clotting
470959 - potential for safe surgery today.
470960 -
470961 -            [...below, additional blood draws after surgery performed
470962 -            to test new Power Port, included CBC and CA 15-3.
470963 -            ref SDS 0 6F4I
470965 -             ..
470966 -            [...below, INR 1.1 excellent clotting permitted surgery.
470967 -            ref SDS 0 MF4K
470969 -             ..
470970 -            [...below, Millie cut her finger; bleeding fairly severe,
470971 -            but eventually clotted due to coincidence of having paused
470972 -            Coumadin a week ago. ref SDS 0 BU9X
470973 -
470974 -
470976 -  ..
4710 -
4711 -
4712 - 0900
4713 -
471301 - Power Port Surgery Replace Port Catheter Right Side
471302 - Surgery Power Port Implant Right Side Remove Replace Port Catheter
471303 -
471304 - Millie in surgery for Power Port.
471306 -  ..
471307 - The doctor recalled Millie's letter yesterday on 080707 reporting
471308 - pulmonary embolism. ref SDS 23 4Q5V   Pressure sensitive equipment was
471309 - wrapped on both legs below the knee that monitor and maintain
471310 - pulmonary conditions to prevent blood clots during surgery.
471312 -  ..
471313 - Bard manufacturer's implantation instructions are listed in
471314 - documentation received from Kaiser after surgery, and reviewed below.
471315 - ref SDS 0 L362
471317 -  ..
471318 - Bard lists detailed steps for following surgery procedures required
471319 - to implant the Power Port...
471320 -
471321 -        1.  Cut down.......................... ref SDS 0 6E5J
471322 -        2.  Precutaneous...................... ref SDS 0 XM4L
471323 -        3.  Peel-Apart Sheath
471324 -            Introducer Instructions........... ref SDS 0 QS5M
471325 -        4.  Catheter Tunneling
471326 -            Procedure......................... ref SDS 0 QVST
471327 -        5.  Connect Catheter to Port.......... ref SDS 0 PX6M
471328 -        6.  Position Port and Close
471329 -            Incision Site..................... ref SDS 0 Y64F
471331 -  ..
471332 - Bard lists detailed steps for injecting CT test contrast medium, which
471333 - seem to suggest training and experience using the Power Port are
471334 - factors that need verification. ref SDS 0 JE7N
471336 -  ..
471337 - Was "port system volume" determined for Millie and posted to her
471338 - medical chart, as called out in Power Port product documentation,
471339 - shown below. ref SDS 0 XJ57
471341 -  ..
471342 - Need the name of the doctor who did the anesthetic IV and assisted the
471343 - surgeon during the operation.
471345 -  ..
471346 - We need the doctor's work report on the surgery today, per below.
471347 - ref SDS 0 UH6H
471348 -
471349 -        1.  Power Port documentation describes doctor completing an
471350 -            "implant record" with specified scope. ref SDS 0 666F
471352 -  ..
471353 - Patient Guide for Power Port says patient should show care providers
471354 - Power Port identification card for all procedures related to port
471355 - access. ref SDS 0 3S4P
471357 -  ..
471358 - Millie's Power Port Identification card, ref SDS 0 PPRR, has data
471359 - codes called out in the Bard documentation, ref SDS 0 666F,
471360 -
471361 -            1.  REF............
471365 -                 ..
471366 -            2.  LOT............
471370 -  ..
471371 - Chest xray performed after surgery verfied correct configuration for
471372 - Power Port, following procedure for the original port surgery on
471373 - 040419. ref SDS 5 WQ7I
471374 -
471375 -            [...below, xray findings are reported. ref SDS 0 UY3I
471376 -
471377 -            [...below, the doctor issued a letter to Millie reporting
471378 -            the Power Port was tested successfuly. ref SDS 0 BF4K
471379 -
471380 -
471381 -
471382 -
471383 -
471385 -  ..
4714 -
4715 -
4716 - 1014
4717 -
471701 - Annoying Complex Case Management Accuracy Many Details Stressful
471702 - Surgery Successful Huber Needle Implanted for Treatment at UCSF
471703 - Huber Needle Implanted for Treatment at UCSF Surgery Successful
471704 -
471705 - Doctor Riley Paul post-op consultation.
471707 -  ..
471708 - Labs for the blood draw early this morning showed sufficient clotting
471709 - potential of INR 1.1 to enable safe surgery, per below. ref SDS 0 MF4K
471711 -  ..
471712 - Surgery completed successfully removing the port catheter and
471713 - implanting a new Power Port.
471715 -  ..
471716 - The doctor was thorough addressing issues Millie presented in the
471717 - letter to Kaiser yesterday for case management. ref SDS 23 RT9I
471719 -  ..
471720 - On 080626 UCSF requested a certificate from Kaiser stating the Power
471721 - Port has been tested for use. ref SDS 20 MZ9L  The doctor seemed
471722 - annoyed today.  She recalled getting the letter from the primary care
471723 - physician advising that UCSF requests a "certificate" on suitability
471724 - for use, ref SDS 21 7Y6I, and intended to request clarification, but
471725 - did not have time.  She does not know what a "certificate" means,
471726 - since this is not standard Kaiser documentation for medical practice
471727 - for surgery.  Kaiser can submit the xray report that says the the tip
471728 - of the port catheter overlies the right atrium.  No pneumothroax, per
471729 - below. ref SDS 0 UY3I  The xray does not relate suitability for use.
471730 - She will write a letter saying the port is ready for use.
471732 -  ..
471733 - Coordinating case management creates stress and anxiety that annoys
471734 - everbody because communication is complex and so hard to align.
471735 - Accuracy therefore takes extra time to avoid mistakes, noted by Peter
471736 - Drucker reviewed on 931130. ref SDS 2 3851  Another example occurred
471737 - on 080627 when the primary care physician had to invest extra time to
471738 - coordinate with the Infusion Clinic to support using the Power Port
471739 - implanted with surgery today for the CT test on 080718. ref SDS 21
471740 - GO3G
471742 -             ..
471743 -            [...below, Millie reports the doctor commented on being
471744 -            annoyed by coordination referral details. ref SDS 0 OK8M
471746 -             ..
471747 -            [...below, the doctor issued a letter to Millie reporting
471748 -            the Power Port was tested successfuly. ref SDS 0 BF4K
471750 -             ..
471751 -            [On 080710 Millie submitted the doctor's letter to UCSF,
471752 -            ref SDS 26 EE4O, the nurse advised that UCSF actually needs
471753 -            the report on the xray performed showing placement of the
471754 -            Power Port, see below, ref SDS 0 UY3I, UCSF management
471755 -            called Kaiser; the Surgery department coordinated
471756 -            submission of the xray report to the Infusion Clinic at
471757 -            UCSF. ref SDS 26 TM5J
471759 -             ..
471760 -            [On 081021 Doctor Riley-Paull provided guidance to adjust
471761 -            annoying complex referral from Oncology in time for Millie
471762 -            to get FNA biopsy and status change check to qualify for
471763 -            new treatment of progressing cancer. ref SDS 38 415L
471765 -             ..
471766 -            [On 081022 after successful biopsy, Millie thanked Doctor
471767 -            Riley-Paull for assistance adjusting annoying referral to
471768 -            align with patient history in time for Millie to get
471769 -            treatment for cancer. ref SDS 39 HA33
471771 -  ..
471772 - The doctor tested the port for flow both ways.  She drew blood for
471773 - testing CBC which will include ANC (NEUTS for UCSF) and CA 15-3 to
471774 - cross check UCSF ops.  Results on tests today can be obtained from
471775 - primary care physician via email.  Referral coordination by the
471776 - primary care physician on 080627 was effective lining up work today
471777 - with UCSF requirements and patient history, per above. ref SDS 0 T164
471779 -             ..
471780 -            [...below, CBC blood test failed due to clotting at the
471781 -            Huber needle, with low INR 1.1; but not a problem because
471782 -            this will be tested in 2 days at UCSF on 080710.
471783 -            ref SDS 0 MF54
471785 -             ..
471786 -            [...below CA 15-3 test was partly effective; noted sample
471787 -            hemolyzed, results may be affected. ref SDS 0 05YW
471789 -             ..
471790 -            [...below, xray findings are reported. ref SDS 0 UY3I
471792 -             ..
471793 -            [...below Bard manufacturer's instructions call for flow
471794 -            studies, including asperate to verify ability to draw blood
471795 -            through the port. ref SDS 0 EU59
471797 -             ..
471798 -            [On 080709 Millie letter to Kaiser requests submission of
471799 -            blood test report. ref SDS 25 TR6W
471801 -             ..
471802 -            [On 080710 Power Port with Huber needle pre-configured was
471803 -            used at UCSF for Millie's treatment; worked perfectly.
471804 -            ref SDS 26 TZ8I
471806 -             ..
471807 -            [On 080712 letter to medical team reports CA 15-3 142
471808 -            results of labs at Kaiser on 080708 for surgery to implant
471809 -            the Power Port. ref SDS 28 K14R
471811 -  ..
471812 - The new port was moved down slightly from the original position in
471813 - order to give the skin a "rest."  The doctor also removed some tissue
471814 - that had begun to collect around the port.  The new port is now even
471815 - with the skin, rather than protruding slightly, as occurred with the
471816 - prior port catheter replaced today, planned on 080606. ref SDS 14 IT6M
471817 -
471818 -            [On 080709 Millie notified medical team Vicodin was taken
471819 -            for mild pain from surgery today. ref SDS 25 TR6S
471821 -  ..
471822 - The doctor accessed the Power Port with a Huber needle, which was
471823 - "sewn in" for safety to remain in place until Thursday, when Millie
471824 - gets chemotherapy treatment at UCSF on 080710.  The doctor advised
471825 - that nurses are qualified to remove the stitches or a doctor can do it
471826 - at UCSF after treatment on Thursday.
471828 -  ..
471829 - The incision wound to remove the existing port, and implant the Power
471830 - Port, was closed with surgical tape [see step 7 on manufacturer's
471831 - Instructions for Use, below, ref SDS 0 EV4X]  The tape should remain
471832 - and avoid getting wet during a shower, for a week so while the wound
471833 - heals.  The tape will eventually fall off naturally.  The nurse at
471834 - UCSF can inspect, and determine whether to remove the tape or change
471835 - the dressing with fresh tape to extend the healing period.
471836 -
471837 -            [On 080710 Power Port with Huber needle pre-configured was
471838 -            used at UCSF for Millie's treatment; worked perfectly.
471839 -            ref SDS 26 I27G
471841 -             ..
471842 -            [On 080710 after treatment, nurse in the Infusion Clinic
471843 -            removed stitches easily with no discomfort to Millie, after
471844 -            treatment. ref SDS 26 6A6H
471846 -             ..
471847 -            [On 080710 UCSF nurse in Infusion Clinic gives instructions
471848 -            tape applied by the surgeon at Kaiser for the incision
471849 -            wound to heal should remain for a week, and will be
471850 -            evaluated for removal at UCSF. ref SDS 26 DQ7I
471852 -             ..
471853 -            [On 080717 Catherine examined the wound and noted good
471854 -            progress healing; decided to leave the surgical tape in
471855 -            place another week. ref SDS 30 IL3L
471857 -             ..
471858 -            [On 080717 Millie letter to Kaiser commending the surgeon
471859 -            on successful Power Port surgery and accessing the Power
471860 -            Port for Millie's treatment at UCSF 2 days later,
471861 -            ref SDS 31 EF5I; and requesting name of anesthesiologist
471862 -            who did great work. ref SDS 31 623X
471864 -             ..
471865 -            [On 080718 Kaiser had difficulty using the Power Port
471866 -            causing CT test to fail with complications of bleeding and
471867 -            extravasation, ref SDS 32 LK3R; possible problems of
471868 -            incorrect flow rate, did not use high pressure needle,
471869 -            needle too short, needle not fully seated, defective Power
471870 -            Port, defective needle, surgery problems occluded catheter.
471871 -            ref SDS 32 WI7G
471873 -             ..
471874 -            [On 080719 as a result of complications from CT test on
471875 -            080718 causing bleeding throught surgical wound, Julie in
471876 -            Kaiser Infusion Clinic removed the original surgical tape
471877 -            from the Power Port incision wound; inspection shows
471878 -            healing, but possible compromise with slight gap from the
471879 -            bleeding; fresh surgical tape was placed to dress the
471880 -            wound. ref SDS 33 LD87
471881 -
471882 -
471883 -
471884 -
471885 -
471887 -  ..
4719 -
4720 -
4721 - 1110
4722 -
472201 - Recovery Post Surgery Blood Draw Test Power Port Patient Impressions
472202 -
472203 - Visited Millie in post-op recovery.  She looks well.
472204 -
472205 - Millie was conscious during surgery.  She reported feeling concern
472206 - from pressure by the doctor pushing on her chest to implant and
472207 - position the Power Port.  She had the sense there may have been minor
472208 - complications.
472209 -
472210 -            [...below, Bard manufacturer's instructions list warnings,
472211 -            ref SDS 0 2R5G, and present a long list of possible
472212 -            complications with Power Ports. ref SDS 0 9J5J
472214 -  ..
472215 - We need the doctor's work report on the surgery today.
472217 -  ..
472218 - Millie related that both doctors and several nurses commended support
472219 - on patient history discussed this morning for pre-op, per above.
472220 - ref SDS 0 T164  The surgeon explained that case management gets very
472221 - complex and hard to comprehend when people are very busy, and so
472222 - attention to details can seem annoying.  The doctor asked about skills
472223 - and training to manage complex patient history, illustrated by this
472224 - record.  An example is the "certificate" requested by UCSF, per above.
472225 - ref SDS 0 O65F  Another example is notifying the Coagulation Control
472226 - Clinic for pausing Coumadin treatments before surgery, discussed when
472227 - Doctor Enis called yesterday. ref SDS 23 JP7W  When everything works,
472228 - being proactive tending small details seems like unnecessary overkill.
472229 - When work fails, people ask why nobody performed the simple details
472230 - that led to disaster, reported on 921127. ref SDS 1 0674  Case study
472231 - reviewed on 940612 makes the same point. ref SDS 3 8239
472233 -             ..
472234 -            [On 081021 Doctor Riley-Paull provided guidance to adjust
472235 -            annoying complex referral from Oncology in time for Millie
472236 -            to get FNA biopsy and status change check to qualify for
472237 -            new treatment of progressing cancer. ref SDS 38 415L
472239 -             ..
472240 -            [On 081022 after successful biopsy, Millie thanked Doctor
472241 -            Riley-Paull for assistance adjusting annoying referral to
472242 -            align with patient history in time for Millie to get
472243 -            treatment for cancer. ref SDS 39 HA33
472245 -             ..
472246 -            [On 081218 primary care physician explained that accuracy
472247 -            tracking complex case management should focus on important
472248 -            problems, rather than small, inconsequential details.
472249 -            ref SDS 41 6G62
472251 -             ..
472252 -            [On 090213 1140 primary care physician explains long term
472253 -            survival difficult because managing complex case management
472254 -            is very difficult. ref SDS 42 FZ4H
472256 -  ..
472257 - There was discussion today during surgery that Power Ports are not
472258 - intended for blood draws.  Millie's patient history shows port access
472259 - has been effective for weekly blood draws over the past 5 months at
472260 - UCSF, and for monthly blood draws for more than 4 years at UCSF and
472261 - Kaiser.
472262 -
472263 -            [...below Bard manufacturer's instructions call for flow
472264 -            studies, including asperate to verify ability to draw blood
472265 -            through the port. ref SDS 0 EU59
472266 -
472267 -
472268 -
4723 -

SUBJECTS
Default Null Subject Account for Blank Record

4803 -
480401 -  ..
480402 - Coumadin INR 1.1 Reflects Pause Treatment 5 Days Prior to Surgery
480403 - Laboratory Blood Test Results Problems Occurred on Some Tests
480404 -
480405 - Follow up ref SDS 10 439L.
480406 -
480407 - After surgery, the doctor advised that test results for the blood draw
480408 - this morning, per above, ref SDS 0 K39F, showed INR 1.1, which
480409 - demonstrated sufficient clotting potential to allow Millie's surgery.
480410 - This is below the target range of INR 2.0 - 3.0 for Pulmonary Embolism
480411 - case management.  Low INR today reflects that Millie stopped taking
480412 - Coumadin on 080703, reported to Kaiser in the pre-op scope letter
480413 - yesterday, 080707, ref SDS 23 JP7W, and citing planning with the
480414 - surgeon on 080606. ref SDS 14 UQ4N
480416 -  ..
480417 - Note that INR 1.1 is not clear in the document received from Kaiser
480418 - for the blood test.  The documents indicate some tests were cancelled,
480419 - and others had problems with the specimen. ref SDS 0 075H
480420 -
480421 -            [...Gloria called with a revised treatment plan for
480422 -            Coumadin to increas INR back to the safe range required for
480423 -            managing Millie's pulmonary embolism. ref SDS 0 PSPS
480425 -  ..
480426 - After the surgery, the doctor drew blood for additional tests, noted
480427 - earlier by the doctor, per above. ref SDS 0 6F4I
480428 -
480429 -            [...below, the doctor issued a letter to Millie reporting
480430 -            the Power Port was tested successfuly. ref SDS 0 BF4K
480432 -  ..
480433 - There was a blood clot found in the first vial of the blood draw
480434 - through the port, and this caused failure of the test for the CBC
480435 - "panel."  The other panels evidently were successful.  Clotting in the
480436 - initial blood draw aligns with low INR 1.1 from Millie having paused
480437 - Coumadin last week.
480438 -
480439 -            [On 080709 Millie's letter to medical team requests results
480440 -            of blood test at Kaiser today. ref SDS 25 TR6W
480442 -             ..
480443 -            [On 080712 letter to medical team reports CA 15-3 142
480444 -            results of labs at Kaiser on 080708 for surgery to implant
480445 -            the Power Port. ref SDS 28 K14R
480447 -  ..
480448 - Millie decided that since she is getting a blood test in 2 days at
480449 - UCSF on Thursday, 080710, making another blood draw for the CBC panel
480450 - would not be cost effective.  The doctor therefore did not order work
480451 - to correct failure of the CBC lab today.
480452 -
480453 -
480468 -     ..
480469 -    Log#:                   080708 09:50
480470 -    <----------------------- K a i s e r ------------------->
480471 -    Type                 Results   Units        Normal        ACRO
480472 -     ..
480473 -    CBC with DIFF & PLT CT                                     CBCD
480474 -     ..
480475 -    WBC COUNT       Test Canceled  K/uL        3.4  -   10     WBC
480476 -    RBC COUNT       Test Canceled  M/uL       3.60  -   5.70   RBC
480477 -    RDW, RBC        Test Canceled  %          11.9  -  14.3    RBC
480478 -    HEMOGLOBIN      Test Canceled  g/dL       11.5  -   15.0   HGB
480479 -    HEMATOCRIT      Test Canceled  %            34  -   46     HCT
480480 -    MCV             Test Canceled  fL           80  -   100    MCV
480481 -    MCH             Test Canceled  pg           26  -   34     MCH
480482 -    MCHC            Test Canceled  g/dL         31  -   36     MCHC
480483 -    PLATELETS x10-3 Test Canceled  K/uL        140  -  400     PLT
480485 -     ..
480486 -    Neutrophils     Test Canceled  %            50  -   70
480488 -     ..
480489 -    Lymphocytes     Test Canceled  %            20  -   50     L-A
480490 -    MONOS           Test Canceled  %             0  -   11     M-A
480491 -    Eosinophils     Test Canceled  %             1  -    5     E-A
480492 -    Basophil        Test Canceled  %             0  -    2     B-A
480493 -     ..
480494 -    PT Patient             11.0    Sec         9.1  -   11.2
480495 -     ..
480496 -    CA 15-3               141      U/mL             -<  39
480497 -
480498 -         Comment:  Specimen slightly hemolyzed.  Results may be
480499 -         affected.
480500 -
480501 -         Not sure which test this comment references.  Suggests results
480502 -         may be incorrect.  Millie's evidence of subsiding IBC disease
480503 -         seems conflicting with significantly elevated cancer marker.
480504 -
480506 -     ..
480507 -    <----------------------- K a i s e r ------------------->
480508 -    Type                 Results   Units        Normal        ACRO   Type
480509 -    ELECTROLYTE PANEL                                          LYTE
480510 -    SODIUM                139      mEq/L       137  -  145     NA
480511 -    POTASSIUM    H*         5.4    mEq/L       3.5  -  5.3     K
480512 -    CHLORIDE     H*       111      mmol/L       98  -  107     CL
480513 -    ANION GAP               8      mEq/L         5  -  16      ANGA
480514 -     ..
480515 -    BUN                     9      mg/dL         7  -  17      BUN
480516 -    GLUCOSE RANDOM         86      mg/dL        60  -  159     GLU
480518 -     ..
480519 -    CREAT with eGFR
480520 -    CREATININE              0.39   mg/dL      0.60  - 1.20     CR
480521 -
480522 -         Specimen grossly hemolyzed.  Results may be affected
480523 -
480524 -         Not sure which test this comment references.
480526 -     ..
480527 -    eGFR if Caucasian     >60      mL/min                      GFRC
480528 -    eGFR if African Amer  >60      mL/min                      GFRA
480529 -
480530 -
480532 -  ..
480533 - CA 15-3 141 Cancer Marker Rises Highest Results Possibly Incorrect
480534 - Cancer Marker Alarming Increase Sample Hemolyzed Results May Be Affected
480535 -
480536 - A few days after surgery today, the primary care physician submitted
480537 - results for the cancer marker from the labs today for surgery.
480539 -  ..
480540 - CA 15-3 141 is 40% higher than previously recorded in Millie's patient
480541 - history. ref SDS 0 05YW  Presents alarming prospect of accelerating
480542 - progression of disease.  Laboratory comment that the "specimen was
480543 - slightly hemolyzed, so results may be affected," ref SDS 0 05YW, align
480544 - with report that a large part of the test could not be performed, per
480545 - above, ref SDS 0 075H, and citing a blood clot in the port that caused
480546 - some tests to fail. ref SDS 0 MG6M
480548 -  ..
480549 - Millie's most recent test for CA 15-3 72 at UCSF on 080626 showed
480550 - slight increase, ref SDS 20 PW7I, so some increase today could be
480551 - expected.  There is also a differential based on calibration methods
480552 - that causes results testing the cancer marker at Kaiser to be
480553 - inherently higher than at UCSF.  Generally, CA 15-3 72 at UCSF might
480554 - be 90 at Kaiser.  Therefore, CA 15-3 141 at Kaiser might be 110 or so
480555 - at UCSF, which would represent a 60% increase from the test on 080626.
480557 -  ..
480558 - Elevated cancer marker seems conflicting with evident stable to
480559 - improved IBC rash, and no clinical findings of lymphadenopathy, shown
480560 - by examination at UCSF on 080626. ref SDS 19 FH7M  Accordingly, the
480561 - pending CT test on 080718 will help resolve questions raised by labs
480562 - today reporting an unusually high cancer marker. ref SDS 0 M45H
480563 -
480564 -        [On 080712 Millie reports concern to medical team about cancer
480565 -        marker CA 15-3 142 results from labs at Kaiser for Power Port
480566 -        surgery on 080708, ref SDS 28 JN3K, and notes conflict with
480567 -        evident subsiding IBC rash. ref SDS 28 K14U
480569 -         ..
480570 -        [On 080712 Millie asks medical team about new treatments since
480571 -        meeting at UCSF on 070130. ref SDS 28 K15P
480573 -         ..
480574 -        [On 080724 CA 15-3 71 at UCSF shows stable cancer marker;
480575 -        corrects compromised labs for the cancer marker ("hemolyzed")
480576 -        at Kaiser today on 080708, ref SDS 0 05YW, and aligns with
480577 -        clinical findings on 080626 showing stable to improved
480578 -        condition. ref SDS 34 KE6G
480580 -         ..
480581 -        [On 080821 CA 15-3 96 at UCSF shows significant increase in
480582 -        cancer marker, ref SDS 36 LQ3O, may reflect new findings from
480583 -        examination of swelled lymph nodes in
480584 -        left supraclavicular.
480585 -
480586 -
480587 -
480589 -  ..
4806 -
4807 -
4808 - 1148
4809 -
480901 - Discharge Power Port Packet and Vicodin Medication for Pain
480902 - Vicodin Pain Medication Prescribed for Home Care after Discharge
480903 - Pain Surgery Recovery Home Care Vicodin Prescribed after Discharge
480904 -
480905 - Maria is getting Millie ready for discharge.
480907 -  ..
480908 - The doctor prescribed Vicodin in case Millie has any pain from the
480909 - surgery after the local anesthetic begins to subside.
480910 -
480911 -     [...below Millie begins to experience pain after midnight; takes
480912 -     Vicodin. ref SDS 0 TL4O
480913 -
480914 -
480916 -  ..
4810 -
4811 -
4812 - 1222
4813 -
481301 - Millie discharged.
481303 -  ..
481304 - Maria submits...
481305 -
481306 -        1.  Power Port Packet Patient Instructions (reviewed below.
481307 -            ref SDS 0 DZ5O
481308 -
481309 -            Important for Millie to notify care providers she has a
481310 -            Power Port, which requires particular procedures for
481311 -            access, see below. ref SDS 0 JE7N
481313 -             ..
481314 -        2.  Vicodin medication prescribed for pain.
481316 -      ..
481317 -     [On 080709 Millie notified medical team Vicodin was taken for mild
481318 -     pain from surgery today. ref SDS 25 TR6S
481320 -      ..
481321 -     [On 080710 UCSF nurse in Infusion Clinic gives instructions on
481322 -     removing adhesion tape applied by the surgeon at Kaiser for the
481323 -     surgical incision to heal. ref SDS 26 6B3O
481325 -  ..
481326 - Maria said to drive the car from parking garage to the Emergency
481327 - parking lot in front of the main entrance to the hospital.
481329 -  ..
481330 - Got the car, and parked per instructions.
481332 -  ..
481333 - Picked up prescription for Vicodin medication at Discharge Pharmacy
481334 - just inside the hospital at the entrance from the Emergency parking
481335 - lot.
481337 -  ..
481338 - Cost $12.00
481339 -
481340 -     [...below Millie begins to experience pain after midnight; takes
481341 -     Vicodin. ref SDS 0 TL4O
481343 -  ..
481344 - Millie is brought outside the hospital in a wheel chair pursuant to
481345 - new regulations, even though she was strong and clear-headed enough to
481346 - walk.
481348 -  ..
481349 - There was a mixup on the location on the meaning of the "circle"
481350 - parking lot.  When Millie did not show up after 15 minutes, went back
481351 - to the Surgery Department on the 2nd floor.  Maria called the
481352 - attendant on a two-way radio to coordinate the release point.
481354 -  ..
481355 - Millie eventually arrived outside the hospital at the Emergency
481356 - parking lot, and we drove home.
481357 -
481358 -
481359 -
481360 -
481362 -  ..
4814 -
4815 -
4816 - 1245
4817 -
481701 - Recovery Same Day at Home Power Port Surgery
481702 -
481703 -
481704 - Arrived home.
481705 -
481706 - Millie was initially hungry.  Fixed grilled cheese sandwich and glass
481707 - of milk.
481708 -
481710 -  ..
4818 -
4819 -
4820 - 1328
4821 -
482101 - After lunch, Millie was tired.  She layed down but did not sleep.
482102 - Watched some television.
482104 -  ..
482105 - She called her friend Marilyn in Chicago, and another friend, Judy.
482107 -  ..
482108 - Judy had bad news, her cancer relapsed from 7 years ago, and she had
482109 - a mastectomy.
482110 -
482112 -  ..
4822 -
4823 -
4824 - 1549
4825 -
482501 - Millie goes grocery shopping at Costco.
482502 -
482503 -
482504 -
4826 -

SUBJECTS
Default Null Subject Account for Blank Record

4903 -
4904 - 1624
490501 -  ..
490502 - Coumadin Treatment Plan Increase INR Reduce Risks Blood Clots PE
490503 - INR Low Treatment Plan Reduce Blood Clot Risk Pulmonary Embolism
490504 - Pulmonary Embolism Case Management Treatment Plan Avoid Blood Clots
490505 -
490506 - Gloria called with Kaiser Coagulation Control Clinic in Martinez.
490507 -
490508 - Gloria received Millie's letter yesterday, 080707 advising that Millie
490509 - is scheduled for surgery today.
490511 -  ..
490512 - Gloria was notified by Kaiser's computer system that Millie's blood
490513 - test today for surgery reported INR 1.1.  This aligns with discussion
490514 - with the doctor today, per above, ref SDS 0 MF4K; however this reading
490515 - is not clear in the copy of the report for the blood test received
490516 - from Kaiser today, per above. ref SDS 0 075H
490518 -  ..
490519 - Gloria changes the treatment plan for pulmonary embolism during the
490520 - next few days.
490521 -
490522 -    1.  This week only, today and tomorrow (Tuesday and Wednesday)
490523 -        increase Coumadin to 6 mg per day.
490524 -
490525 -    2.  Thursday continue 6 mg treatment normally prescribed for
490526 -        Thursday only.
490528 -         ..
490529 -    3.  Continue standard prescription.
490531 -         ..
490532 -    4.  Blood test INR at UCSF on 080717 to evaluate recovery from INR
490533 -        1.1 today to the required range of INR 2.0 - 3.0 for pulmnary
490534 -        embolism patients.
490535 -
490536 -            [On 080709 Millie submitted a letter to the medical team,
490537 -            including Catherine at UCSF notifying that Kaiser needs
490538 -            blood test on INR for treatment on 080717. ref SDS 25 TR8W
490540 -             ..
490541 -            [On 080717 UCSF included INR in blood test. ref SDS 30 IL75
490543 -             ..
490544 -            [On 080724 mixup omitted INR from blood test starting next
490545 -            cycle, was mitigate by having done INR week earlier on
490546 -            080717 to recover from pause in Coumadin for surgery.
490547 -            ref SDS 34 IU8H, INR was later added to blood test, and
490548 -            results were 2.4, within the target range. ref SDS 34 K66J
490550 -         ..
490551 -        Labs at UCSF for Millie are scheduled to test INR every 4
490552 -        weeks, when Millit starts a new cycle of chemotherapy treatment
490553 -        for cancer.  The next cycle starts on 080724.  Millie will ask
490554 -        UCSF to test for INR a week early to meet Kaiser requirements.
490556 -         ..
490557 -        Millie could get Creatinine tested on 080717 also, which is
490558 -        needed for the CT test the next day at Kaiser on 080718.  The
490559 -        test for Creatinine today has a comment that results could be
490560 -        affected because the specimen was grossly hemolyzed.
490561 -        ref SDS 0 8U4N
490562 -
490563 -            [On 080711 Ike asked Millie about getting a blood test for
490564 -            Creatinine; reported results of the test today at Kaiser
490565 -            (080708) may not be reliable. ref SDS 27 JQ4U
490566 -
490568 -  ..
490569 - Gloria will submit a letter to Millie through Kaiser's electronic
490570 - email system.
490571 -
490573 -  ..
4906 -
4907 -
4908 - 1944
4909 -
490901 - Millie received
490902 -
490903 -
490904 -
490905 -
490906 -
490907 -
490908 -
4910 -

SUBJECTS
Default Null Subject Account for Blank Record

5003 -
5004 - 1657
500501 -  ..
500502 - Patient Cannot Rest Post Surgery Hyper Active
500503 -
500504 - Millie returns from shopping at Costco.
500505 -
500507 -  ..
5006 -
5007 -
5008 - 1738
5009 -
500901 - Power outage.
500902 -
500903 - Millie got a call from a friend in the complex.  She took some chicken
500904 - to Janna who lives a block a way.
500905 -
500906 -
500908 -  ..
5010 -
5011 -
5012 - 1922
5013 -
501301 - Bleeding Cut Finger Blood Clots Normally with Low INR
501302 -
501303 - Millie returns home.  She is cutting chicken in the dark due to the
501304 - power outage, and cuts her finger.
501306 -  ..
501307 - Difficulty stopping the blood flow.  Millie jokes she is lucky there
501308 - was a power outage that caused a cut finger on the one day when her
501309 - INR is lower than normal for a PE patient, because she paused Coumadin
501310 - treatments a week ago.  What are the odds?
501312 -  ..
501313 - Help Millie place a bandage on the finger.
501315 -  ..
501316 - Bleeding continues, because the bandage got wet from washing dishes.
501318 -  ..
501319 - Patient continues still hyper-active.
501321 -  ..
501322 - Getting a little worried about bleeding.  Millie eventually wrapped
501323 - the finger in guaze, sat down, elevated her hand, and the bleeding
501324 - stopped.
501325 -
501326 -
501328 -  ..
5014 -
5015 -
5016 - 2113
5017 -
501701 - Sleep Difficult Stress Anxiety Surgery Power Outage Cut Finger
501702 -
501703 - Power restored.
501704 -
501705 - Millie watching television.
501706 -
501707 -
501709 -  ..
5018 -
5019 -
5020 - 2245
5021 -
502101 - Millie still not asleep.  Normally she is asleep by 2100.
502102 -
502103 - She was up this morning at 0445, and has not slept all day.  She has
502104 - been active all day.
502105 -
502107 -  ..
5022 -
5023 -
5024 - 2321
5025 -
502501 - Millie still up; turns television off to sleep.
502502 -
502503 -
502505 -  ..
5026 -
5027 -
5028 - 0026
5029 -
502901 - Vicodin Medication Relieves Mild Pain Surgery Trauma
502902 - Pain Mild Surgery Trauma Relieved by Vicodin Medication
502903 -
502904 - Millie begins feeling mild pain at the surgery location.
502905 -
502906 - Takes Vicodin prescribed for pain, and received from the Discharge
502907 - Pharmacy earlier today. ref SDS 0 U24M
502908 -
502909 -     [On 080709 Millie notified medical team Vicodin was taken for mild
502910 -     pain from surgery today. ref SDS 25 TR6S
502911 -
502912 -
502913 -
502914 -
502915 -
5030 -

SUBJECTS
Power Port Surgery Implant Documentation Surgeon Certificate Device

6203 -
620401 -  ..
620402 - Power Port Certificate Tested Successfully
620403 -
620404 - Millie received ref DRT 1 0001 a letter dated today from Kaiser and
620405 - signed by the surgeon saying...
620406 -
620407 -        This Letter is to confirm that your portacath was successfully
620408 -        revised today and changed to a Power Port type device.  The
620409 -        port was functional at the time of the insertion - it asperated
620410 -        and injected freely.  A Huber needle was left in the port for
620411 -        use as soon as it is needed.
620413 -  ..
620414 - Kaiser's letter today implements discussion with the doctor during
620415 - post-op consultation, above, ref SDS 0 O65F, responds to UCSF request
620416 - on 080626 for written confirmation from Kaiser that the Power Port was
620417 - tested successfully. ref SDS 20 MZ9L  Good coordination between
620418 - Oncology and Surgery departments, implementing notice from primary
620419 - care physician on 080627, and cited in Millie's letter to the medical
620420 - team on 080702. ref SDS 22 EQ3W
620421 -
620422 -            [...below Bard manufacturer's instructions call for flow
620423 -            studies, including asperate to verify ability to draw blood
620424 -            through the port. ref SDS 0 EU59
620426 -             ..
620427 -            [On 080710 Millie submitted the doctor's letter to UCSF,
620428 -            ref SDS 26 EE4O, the nurse advised that UCSF actually needs
620429 -            the report on the xray performed showing placement of the
620430 -            Power Port, see below, ref SDS 0 UY3I, UCSF management
620431 -            called Kaiser; the Surgery department coordinated
620432 -            submission of the xray report to the Infusion Clinic at
620433 -            UCSF. ref SDS 26 TM5J
620435 -             ..
620436 -            [On 080715 consider leaving Huber needle in place for
620437 -            treatment at UCSF on 080717 in order to be used for CT test
620438 -            the next day at Kaiser on 080718. ref SDS 29 RB97
620440 -             ..
620441 -            [On 080717 Millie letter to Kaiser commending the surgeon
620442 -            on successful Power Port surgery and accessing the Power
620443 -            Port for Millie's treatment at UCSF 2 days later,
620444 -            ref SDS 31 EF5I; and requesting name of anesthesiologist
620445 -            who did great work. ref SDS 31 623X
620446 -
620447 -
620449 -  ..
620450 - Xray Test Report Favorable Findings Power Port Catheter
620451 -
620452 - An xray test was performed after surgery, per above. ref SDS 0 O67N
620454 -  ..
620455 - The xray report shows...
620456 -
620457 -    Kaiser Walnut Creek        Category       From Date To Date
620458 -    72/F Radiology Report      Radiology        080409   080708
620459 -
620460 -    Patient                      Personal Physician
620463 -     ..
620464 -    Portable Chest Xray (Digital)
620466 -     ..
620467 -    Ordered by..
620468 -
620471 -    ...on 080708 1027 at WCR Inpatient.
620473 -     ..
620474 -    Performed in:  WCR - Read by...
620475 -
620476 -                LB Gordon, MD
620478 -     ..
620479 -    History
620480 -
620481 -        S/p port revision
620483 -     ..
620484 -    Findings
620485 -
620486 -        Since the former examination of 080409, patient has had port
620487 -        revision.  The tip of the port catheter now overlies the right
620488 -        atrium.  No pneumothroax.  Otherwise negative chest with
620489 -        otherwise no change.
620490 -
620493 -
620494 -
620495 -
6205 -

SUBJECTS
Default Null Subject Account for Blank Record

6303 -
630401 -  ..
630402 - Documentation Power Port Packet
630403 - Power Port Packet Documentation
630404 -
630405 - Millie received a Power Port patient packet...
630406 -
630407 -        BARD Access Systems, Inc
630408 -        Salt Lake City, UT  84116 USA
630409 -        801 595 0700
630410 -
630411 -            [On 080710 Millie reviewed Power Port documentation with
630412 -            nurse at the UCSF Infusion Clinic. ref SDS 26 EE54
630414 -             ..
630415 -            [On 080715 Arlette received Millie's Power Port Patient
630416 -            Packet for guidance assigning personnel to support the CT
630417 -            test on 080718. ref SDS 29 RB4G
630419 -             ..
630420 -            [On 080718 Kaiser had difficulty using the Power Port
630421 -            causing CT test to fail with complications of bleeding and
630422 -            extravasation, ref SDS 32 LK3R; possible problems of
630423 -            incorrect flow rate, did not use high pressure needle,
630424 -            needle too short, needle not fully seated, defective Power
630425 -            Port, defective needle, surgery problems occluded catheter.
630426 -            ref SDS 32 WI7G
630428 -             ..
630429 -            [On 080801 Bard Field Services reports that Bard can only
630430 -            sell Huber needles for Powerloc Safety Set to perform CT
630431 -            tests with written evidence that the person who uses the
630432 -            needle for CT tests has been trained to implement Bard
630433 -            Power Injection Procedures. ref SDS 35 OV69
630434 -
630436 -         ..
630437 -        Clinical Information Hotline
630438 -        800 443 3385
630439 -
630440 -              http://www.bardaccess.com
630441 -
630442 -              http://www.portadvantage.com
630444 -         ..
630445 -        Power Port
630447 -         ..
630448 -        Implantable Port
630449 -        Feel the New Standard of Care
630450 -
630452 -         ..
630453 -        Patient Discharge Packet
630455 -         ..
630456 -        Important
630458 -         ..
630459 -        This packet contains patient information and identification
630460 -        materials.
630462 -         ..
630463 -        Patient Discharge Packet Contents
630465 -         ..
630466 -        Identification Card for Power Port with Lot #
630467 -
630468 -        Carry this card with you to show your medical professional
630469 -        whenever your port is accessed.  Your identification card
630470 -        provides a summary of important information they should know
630471 -        about your Power Port device.
630473 -         ..
630474 -        This card has instructions on the back for using the Power
630475 -        Port, including guidance on flushing the port after use to
630476 -        maintain optimal flow, per below. ref SDS 0 EM3L
630477 -
630478 -            [On 080710 Catherine helped Millie fill out the ID card,
630479 -            and made a copy of port flush instructions on the back for
630480 -            Millie's medical record at UCSF. ref SDS 26 YC61
630482 -             ..
630483 -            [On 080718 Nora asks for Millie's Power Port ID to get
630484 -            guidance on flushing the port. ref SDS 32 2U8V
630486 -             ..
630487 -            [On 081107 Heather asks for Millie's Power Port ID to get
630488 -            guidance on setting injection pressure for CT test contrast
630489 -            medium. ref SDS 40 2F32
630491 -         ..
630492 -        The card also shows data requested to uniquely identify the
630493 -        Power Port, per below, ref SDS 0 666F, as follows...
630494 -
630500 -         ..
630501 -        Bracelet
630503 -         ..
630504 -        Wear this bracelet as a reminder to tell your medical
630505 -        professional that you have a Power Port implanted port.
630506 -
630508 -         ..
630509 -        Key Ring Card
630511 -         ..
630512 -        Keep this key ring as a reminder to tell your medical
630513 -        professional that you have a Power Port implanted port.
630514 -
630515 -
630517 -         ..
630518 -        Documentation for Power Port
630519 -
630520 -        Instructions for use....................... ref SDS 0 D67I
630522 -         ..
630523 -        CT test inject contrast medium............. ref SDS 0 JE7N
630525 -         ..
630526 -        Air Guard Valved Introducer................ ref SDS 0 EN63
630528 -         ..
630529 -        Patient Guide.............................. ref SDS 0 EX82
630531 -         ..
630532 -        The patient-specific information contained in this guide gives
630533 -        you the knowledge to understand and feel comfortable with your
630534 -        Power Port implanted port.  It also gives you the power to
630535 -        inform medical professionals about your Power Port device.
630536 -
630538 -         ..
630539 -        Companion Checklist
630541 -         ..
630542 -        The checklist provides your companion with valuable information
630543 -        about your Power Port implanted port and how to use the
630544 -        contents of this packet.
630545 -
630547 -         ..
630548 -        Bard Power Port, Powerloc
630549 -
630550 -        "Feel the new standard of care," and the color purple are
630551 -        trademarks and/or registered trademarks of CR Bard, Inc, or an
630552 -        affiliate.  The unique purple body indicates that the Power
630553 -        Port device is a Bard Power injectable port.
630555 -         ..
630556 -        0713273 0605R
630557 -
630558 -
630559 -
630560 -
6306 -

SUBJECTS
Default Null Subject Account for Blank Record

6403 -
640401 -  ..
640402 - Within the packet there is a manual with very small print...
640404 -         ..
640405 -        Power Port
640406 -        Implanted Port System
640408 -         ..
640409 -        Instructions for Use
640410 -
640412 -  ..
640413 - Found a website that has this content...
640414 -
640415 -              http://www.bardaccess.com/ifus.php
640417 -  ..
640418 - Bard posts a pdf file...
640419 -
640420 -              http://www.bardaccess.com/pdfs/ifus/0716577_powerport_isp_web.pdf
640422 -  ..
640423 - Instructions for Use continues...
640424 -
640425 -        An issued or revision date for these instructions is included
640426 -        for the user's information. In the event two years have
640427 -        elapsed between this date and product use, the user should
640428 -        contact Bard Access Systems, Inc. to see if additional
640429 -        product information is available.
640431 -         ..
640432 -        Revised date: November 2007
640434 -  ..
640435 - Note:  the Power Port packet Millie received today from Kaiser shows
640436 -
640437 -                Revised date: November 2006
640439 -  ..
640440 - Since the date today is 080708, this is over 2 years from the revised
640441 - date for the documentation received from Kaiser.  Therefore, per
640442 - Bard's instruction, this record shows content from the updated revised
640443 - date of November 2007 shown in the Internet.
640445 -  ..
640446 - Instructions for Use continues...
640447 -
640448 -        U.S. Patent 6,997,902 and other patents pending.
640449 -        Copyright 2007 C. R. Bard, Inc. All rights reserved.
640451 -         ..
640452 -        Bard Access Systems, Inc.
640453 -        Salt Lake City, UT 84116 USA.................. 801-595-0700
640454 -        Clinical Information Hotline.................. 800-443-3385
640455 -        Ordering Information.......................... 800-545-0890
640456 -
640457 -              http://www.bardaccess.com
640459 -               ..
640460 -              http://www.portadvantage.com
640462 -               ..
640463 -              http://www.powerportadvantage.com
640464 -
640466 -         ..
640467 -        Dear Physician,
640469 -         ..
640470 -        Thank you for giving this patient a PowerPort* device.  This
640471 -        port not only facilitates infusions, but also allows for the
640472 -        power injection of contrast media for CECT scans.  As older
640473 -        technology ports could not withstand power injections, some
640474 -        clinicians may not yet be familiar with a PowerPort* device,
640475 -        and may not recognize that one can receive contrast injections
640476 -        through this port.  To avoid unnecessary needlesticks for this
640477 -        patient, we request your help informing other clinicians of the
640478 -        added utility of this port.  To help other clinicians identify
640479 -        this patient as a patient with a PowerPort* implantable port,
640480 -        please inform the patient that they have received a PowerPort*
640481 -        device and ensure they receive the Patient Discharge Packet
640482 -        that was packaged with the PowerPort* implanted port packaging.
640484 -         ..
640485 -        Thank you,
640487 -         ..
640488 -        Bard Access Systems' Port Team
640489 -
640491 -         ..
640492 -        CT Contrast Enhanced Computer Tompgraphy Information
640493 -
640494 -        New Important Information:
640495 -
640496 -        1)  This device is contraindicated for catheter insertion in
640497 -            the subclavian vein medial to the border of the first rib,
640498 -            an area which is associated with higher rates of
640499 -            pinch-off./1,2
640501 -             ..
640502 -        2)  For power injecting contrast media, a PowerLoc* Safety
640503 -            Infusion Set (SIS) must always be used to access the
640504 -            PowerPort* implanted port.
640506 -             ..
640507 -        3)  Contrast media should be warmed to body temperature prior
640508 -            to power injection.  Warning:  Failure to warm contrast
640509 -            media to body temperature prior to power injection may
640510 -            result in port system failure.
640512 -             ..
640513 -        4)  If possible, the patient should receive power injection
640514 -            with arms vertically above the shoulder with the palms of
640515 -            the hands on the face of the gantry during injection.  This
640516 -            allows for uninterrupted passage of injected contrast
640517 -            through the axillary and subclavian veins at the thoracic
640518 -            outlet.
640520 -             ..
640521 -        5)  Check for patency, via aspiration, then vigorously flush
640522 -            the PowerPort* device with a syringe and sterile normal
640523 -            saline prior to and immediately following the completion of
640524 -            power injection studies.  This will ensure the patency of
640525 -            the PowerPort* implanted port and prevent damage to the
640526 -            port system.  Resistance to flushing may indicate partial
640527 -            or complete catheter occlusion.  Do not proceed with power
640528 -            injection study until occlusion has been cleared.  Warning:
640529 -            Failure to ensure patency of the catheter prior to power
640530 -            injection studies may result in port system failure.
640532 -             ..
640533 -        6)  Do not exceed a 300 psi pressure limit setting, or the
640534 -            maximum flow rate setting shown below, on the power
640535 -            injection machine if power injecting through the PowerPort*
640536 -            device:
640537 -
640538 -                Powerloc SIS Guage   Size      19 Ga    20 Ga    22 Ga
640539 -                Powerloc SIS Wing    Color     Cream    Yellow   Black
640540 -                Maximum Flow Rate    Setting   5 ml/s   5 ml/s   2 ml/s
640542 -         ..
640543 -        Warning:  Do not power inject through a port system that
640544 -        exhibits signs of clavicle-first rib compression or pinch-off,
640545 -        as it may result in port system failure.
640546 -
640547 -                   [On 080718 Kaiser had difficulty using the Power
640548 -                   Port causing CT test to fail with complications of
640549 -                   bleeding and extravasation, ref SDS 32 LK3R;
640550 -                   possible problems of incorrect flow rate, did not
640551 -                   use high pressure needle, needle too short, needle
640552 -                   not fully seated, defective Power Port, defective
640553 -                   needle, surgery problems occluded catheter.
640554 -                   ref SDS 32 WI7G
640556 -         ..
640557 -        Warning:  Power injector machine pressure limiting feature may
640558 -        not prevent over pressurization of an occluded catheter.
640560 -  ..
640561 - Research shows...
640562 -
640563 -               Catheters that present resistance to flushing and
640564 -               aspiration may be partially or completely occluded. Do
640565 -               not flush against resistance. If the lumen will neither
640566 -               flush nor aspirate and it has been determined that the
640567 -               catheter is occluded with blood, a declotting procedure
640568 -               per institution protocol may be appropriate.
640570 -  ..
640571 - Bard Instructins for Use continues...
640572 -
640573 -        Warning:  Exceeding the maximum flow rate may result in port
640574 -        system failure and/or catheter tip displacement.
640575 -
640576 -                   [On 080801 Bard representative lists factors that
640577 -                   cause failure of power injection using the Power
640578 -                   Port. ref SDS 35 OW43
640580 -         ..
640581 -        Warning: If local pain, swelling or signs of extravasation are
640582 -        noted, the injection should be stopped immediately.
640583 -
640584 -                   [On 080718 Kaiser had difficulty using the Power
640585 -                   Port causing CT test to fail with complications of
640586 -                   bleeding and extravasation. ref SDS 32 LK3R
640588 -                    ..
640589 -                   [On 090720 1437 ER refused to use Millie's Power
640590 -                   Port for injecting contrast medium to perform CT
640591 -                   test evaluating Millie's breathing problems caused
640592 -                   by radiatoin injury, ref SDS 43 OK95; this caused
640593 -                   access to fail with trauma to nurses and the
640594 -                   patient's daughter seeing Millie suffer through
640595 -                   multiple attempts to get adequate blood flow with
640596 -                   conventional IV. ref SDS 43 PQ4V
640597 -
640599 -  ..
640600 - Trained Clinician Evaluate Patient Health Suitable Injection Power Port
640601 -
640602 -
640603 - Instructions for Use continues...
640605 -         ..
640606 -        Warning:  PowerPort* Implanted Port indication for power
640607 -        injection of contrast media implies the port's ability to
640608 -        withstand the procedure, but does not imply appropriateness of
640609 -        the procedure for a particular patient nor for a particular
640610 -        infusion set.  A suitably trained clinician is responsible for
640611 -        evaluating the health status of a patient as it pertains to a
640612 -        power injection procedure and for evaluating the suitability of
640613 -        any infusion set used to access the port.
640615 -  ..
640616 - This "warning" of requirement for "trained clinician" to evaluate
640617 - patient status may relate to Bella's concerns at Kaiser reported on
640618 - 080617. ref SDS 17 RP6J
640619 -
640620 -                   [On 080801 Bard Field Services reports that Bard can
640621 -                   only sell Huber needles for Powerloc Safety Set to
640622 -                   perform CT tests with written evidence that the
640623 -                   person who uses the needle for CT tests has been
640624 -                   trained to implement Bard Power Injection
640625 -                   Procedures. ref SDS 35 OV69
640627 -  ..
640628 - This warning is repeated in the section on Warnings during port
640629 - access, below. ref SDS 0 EM79
640631 -  ..
640632 - Instructions for Use continues...
640634 -  ..
640635 - There is an image showing...
640636 -
640637 -            1.  Power Port described as having a "triangular shape"
640638 -                with 3 palpation points arranged in a triange.
640639 -
640640 -            2.  PowerLoc Safety Infusion set with a needle shown
640641 -                penetrating into the Power Port self-sealing silicone
640642 -                septum (described in the document, per below,
640643 -                ref SDS 0 EF5G; there is a Power Port device compatible
640644 -                callout tag also described in the image.
640646 -  ..
640647 - The PowerLoc Safety Infusion Set seems to be the "Huber needle."
640648 -
640649 -                   [On 080801 Bard Field Services reports that Bard can
640650 -                   only sell Huber needles for Powerloc Safety Set to
640651 -                   perform CT tests with written evidence that the
640652 -                   person who uses the needle for CT tests has been
640653 -                   trained to implement Bard Power Injection
640654 -                   Procedures. ref SDS 35 OV69
640656 -  ..
640657 - The design with 3 palpation points and triagular shape enables finding
640658 - the location for accessing the port, step 1 in the Power Injection
640659 - instructions (see below), ref SDS 0 JE7N, which is otherwise invisible
640660 - covered with skin.
640662 -  ..
640663 - Instructions for Use continues...
640665 -         ..
640666 -        Description
640668 -         ..
640669 -        The PowerPort* implanted port is an implantable access device
640670 -        designed to provide repeated access to the vascular system.
640671 -        Port access is performed by percutaneous needle insertion using
640672 -        a non-coring needle.  Power injection is performed using a
640673 -        PowerLoc* Safety Infusion Set only.  The PowerPort* device
640674 -        consists of two primary components: an injection port with a
640675 -        self-sealing silicone septum and a radiopaque open-ended
640676 -        catheter.  PowerPort* implanted ports can be identified
640677 -        subcutaneously by feeling the top of the septum which includes
640678 -        three palpation points arranged in a triangle and by palpating
640679 -        the sides of the port, which is also triangular.  All materials
640680 -        are biocompatible, can be used with virtually all injectable
640681 -        solutions and can be safely used with Cect.
640683 -         ..
640684 -        Contraindications, Warnings, and Precautions
640686 -         ..
640687 -        Contraindications
640689 -         ..
640690 -        This device is contraindicated for catheter insertion in the
640691 -        subclavian vein medial to the border of the first rib, an area
640692 -        which is associated with higher rates of pinch-off/1,2
640694 -         ..
640695 -        The device is also contraindicated:
640696 -
640697 -        1.  When the presence of device related infection, bacteremia,
640698 -            or septicemia is known or suspected.
640700 -             ..
640701 -        2.  When the patient's body size is insufficient for the size
640702 -            of the implanted device.
640704 -             ..
640705 -        3.  When the patient is known or is suspected to be allergic to
640706 -            materials contained in the device.
640708 -             ..
640709 -        4.  If severe chronic obstructive lung disease exists.
640711 -             ..
640712 -        5.  If the prospective insertion site has been previously
640713 -            irradiated.
640715 -             ..
640716 -        6.  If the prospective placement site has previously suffered
640717 -            episodes of venous thrombosis or vascular surgical
640718 -            procedures.
640720 -             ..
640721 -        7.  If local tissue factors will prevent proper device
640722 -            stabilization and/or access.
640723 -
640725 -         ..
640726 -        Warnings
640727 -
640728 -        1.  During Placement:
640729 -
640730 -            1)  Intended for Single Patient Use.  DO NOT REUSE.  Bard
640731 -                Access Systems, Inc. products are single use devices and
640732 -                should never be reimplanted.  Any device that has been
640733 -                contaminated by blood should not be reused or
640734 -                resterilized.
640736 -                 ..
640737 -            2)  After use, this product may be a potential biohazard.
640738 -                Handle and discard in accordance with accepted medical
640739 -                practice and applicable local, state and federal laws
640740 -                and regulations.
640742 -                 ..
640743 -            3)  During placement through a non-AirGuard* peel-away
640744 -                introducer sheath, hold thumb over exposed opening of
640745 -                sheath to prevent air aspiration.  The risk of air
640746 -                aspiration is reduced by performing this part of the
640747 -                procedure with the patient performing the Valsalva
640748 -                maneuver.
640750 -                 ..
640751 -            4)  Do not suture catheter to port, port stem, or
640752 -                surrounding tissue.  Any damage or constriction of
640753 -                catheter may compromise power injection performance and
640754 -                catheter integrity.
640756 -                 ..
640757 -            5)  Avoid vessel perforation.
640759 -                 ..
640760 -            6)  Do not power inject through a port system that exhibits
640761 -                signs of clavicle-first rib compression or pinch-off as
640762 -                it may result in port system failure.
640764 -             ..
640765 -        2.  During Port Access:
640766 -
640767 -            1)  DO NOT USE A SYRINGE SMALLER THAN 10ml.  Prolonged
640768 -                infusion pressure greater than 25 psi may cause damage
640769 -                to a patient's vessels or viscus.
640770 -
640771 -            2)  PowerPort* ports are only power injectable when
640772 -                accessed with a PowerLoc* Safety Infusion Set.
640774 -                 ..
640775 -            3)  Failure to warm contrast media to body temperature
640776 -                prior to power injection may result in port system
640777 -                failure.
640779 -                 ..
640780 -            4)  Failure to ensure patency of the catheter prior to
640781 -                power injection studies may result in port system
640782 -                failure.
640784 -                 ..
640785 -            5)  Power injector machine pressure limiting feature may
640786 -                not prevent over pressurization of an occluded
640787 -                catheter.
640789 -                 ..
640790 -            6)  Exceeding the maximum flow rate may result in port
640791 -                system failure and/or catheter tip displacement.
640793 -                 ..
640794 -            7)  PowerPort* device indication for power injection of
640795 -                contrast media implies the Port's ability to withstand
640796 -                the procedure, but does not imply appropriateness of
640797 -                the procedure for a particular patient nor for a
640798 -                particular infusion set.  A suitably trained clinician
640799 -                is responsible for evaluating the health status of a
640800 -                patient as it pertains to a power injection procedure
640801 -                and for evaluating the suitability of any infusion set
640802 -                used to access the port.
640804 -                 ..
640805 -            8)  Do not exceed a 300 psi pressure limit setting, or the
640806 -                maximum flow rate setting on the power injection
640807 -                machine, if power injecting through the PowerPort*
640808 -                device.
640809 -
640811 -         ..
640812 -        Signs of Pinch-off
640813 -
640815 -  ..
640816 - Power Port devices require monitoring for problems of "pinch off,"
640817 - based on clinical operations and by xray...
640818 -
640819 -                [...below preventing pinch off is presented in the
640820 -                manual. ref SDS 0 X371
640822 -  ..
640823 - Instructions for Use continues...
640824 -
640825 -        Clinical:
640826 -
640827 -        1.  Difficulty with blood withdrawal
640829 -             ..
640830 -        2.  Resistance to infusion of fluids
640832 -             ..
640833 -        3.  Patient position changes required for infusion of fluids or
640834 -            blood withdrawal
640836 -         ..
640837 -        Radiologic:
640838 -
640839 -            Grade 1 or 2 distortion on chest X-ray.  Pinch-off should
640840 -            be evaluated for degree of severity prior to explantation.
640841 -            Patients indicating any degree of catheter distortion at
640842 -            the clavicle/first rib area should be followed diligently.
640843 -            There are grades of pinch-off that should be recognized
640844 -            with appropriate chest x-ray as follows: /3,4
640845 -
640846 -
640847 -            a.  Grade 0
640848 -
640849 -                    Severity
640850 -
640851 -                       No Distortion
640853 -                     ..
640854 -                    Recommended Action
640855 -
640856 -                       No action
640858 -                 ..
640859 -            b.  Grade 1
640860 -
640861 -                    Severity
640862 -
640863 -                       Distortion present without luminal narrowing.
640864 -
640865 -                    Recommended Action
640866 -
640867 -                       Chest xray should be taken one to three months
640868 -                       to monitor progression of pinch off to grade 2
640869 -                       distortion.  Shoulder positioning during chest
640870 -                       xrays should be noted as it can contribute to
640871 -                       changes in distortion grades.
640873 -                 ..
640874 -            c.  Grade 2
640875 -
640876 -                    Severity
640877 -
640878 -                       Distortion present with luminal narrowing.
640879 -
640880 -                    Recommended Action
640881 -
640882 -                       Removal of the catheter should be considered.
640884 -                 ..
640885 -            d.  Grade 3
640886 -
640887 -                    Severity
640888 -
640889 -                       Catheter transection of fracture
640890 -
640891 -                    Recommended Action
640892 -
640893 -                       Prompt removal of the catheter.
640894 -
640896 -         ..
640897 -        Precautions
640898 -
640899 -            1.  Carefully read and follow all instructions prior to
640900 -                use.
640901 -
640902 -            2.  Federal (U.S.A.) law restricts this device to sale by
640903 -                or on the order of a physician.
640905 -                 ..
640906 -            3.  Only qualified healthcare practitioners should insert,
640907 -                manipulate and remove these devices.
640909 -                 ..
640910 -            4.  Avoid inadvertent puncture of the skin or fascia with
640911 -                the tip of the tunneler.
640913 -                 ..
640914 -            5.  If the guidewire must be withdrawn while the needle is
640915 -                inserted, remove both the needle and wire as a unit to
640916 -                help prevent the needle from damaging or shearing the
640917 -                guidewire.
640919 -                 ..
640920 -            6.  Use only non-coring needles with the port.
640922 -                 ..
640923 -            7.  Prior to advancing the catheter lock, ensure that the
640924 -                catheter is properly positioned.  A catheter not
640925 -                advanced to the proper region may not seat securely and
640926 -                lead to dislodgment and extravasation.  The catheter
640927 -                must be straight with no sign of kinking.  A slight
640928 -                pull on the catheter is sufficient to straighten it.
640929 -                Advancing the catheter lock over a kinked catheter may
640930 -                damage the catheter.
640932 -                 ..
640933 -            8.  Follow Universal Precautions when inserting and
640934 -                maintaining the catheter.
640936 -                 ..
640937 -            9.  Follow all contraindications, warnings, precautions and
640938 -                instructions for all infusates as specified by their
640939 -                manufacturers.
640941 -                 ..
640942 -           10.  Precautions are intended to help avoid catheter damage
640943 -                and/or patient injury.
640945 -             ..
640946 -        1.  Prior to Placement:
640947 -
640948 -            1.  Examine package carefully before opening to confirm its
640949 -                integrity and that the expiration date has not passed.
640950 -                The device is supplied in a double sterile package and
640951 -                is non-pyrogenic.  Do not use if package is damaged,
640952 -                opened or the expiration date has passed.  Sterilized
640953 -                by ethylene oxide.  Do not resterilize.
640955 -                 ..
640956 -            2.  Inspect kit for presence of all components.
640958 -                 ..
640959 -            3.  Check patient's records, and ask patient, whether they
640960 -                have any known allergies to chemicals or materials that
640961 -                will be used during the placement procedure.
640963 -                 ..
640964 -            4.  Fill (prime) the device with sterile heparinized saline
640965 -                or normal saline solution to help avoid air embolism.
640966 -                Remember that some patients may be hypersensitive to
640967 -                heparin or suffer from heparin induced thrombocytopenia
640968 -                (HIT) and these patients must not have their port
640969 -                primed with heparinized saline.
640971 -                 ..
640972 -            5.  When using an introducer kit, verify that the catheter
640973 -                fits easily through the introducer sheath.
640975 -             ..
640976 -        2.  During Placement
640977 -
640978 -            1.  Do not allow accidental device contact with sharp
640979 -                instruments. Mechanical damage may occur. Use only
640980 -                smooth edged, atraumatic clamps or forceps.
640982 -                 ..
640983 -            2.  Take care not to perforate, tear, or fracture the
640984 -                catheter during placement.  After assembling catheter
640985 -                to port, check assembly for leaks or damage.
640987 -                 ..
640988 -            3.  Do not use the catheter if there is any evidence of
640989 -                mechanical damage or leaking.
640991 -                 ..
640992 -            4.  Do not bend catheter at sharp angles during
640993 -                implantation. This can compromise catheter patency.
640995 -                 ..
640996 -            5.  Carefully follow the connection technique given in
640997 -                these instructions to ensure proper catheter connection
640998 -                and to avoid catheter damage.
641000 -                 ..
641001 -            6.  Do not use sutures to secure catheter to the port stem
641002 -                as it could collapse or damage the catheter.
641004 -                 ..
641005 -            7.  When using peel-apart introducers:
641006 -
641007 -                a.  Carefully insert the introducer and catheter to
641008 -                    avoid inadvertent penetration to vital structures
641009 -                    in the thorax.
641010 -
641011 -                b.  Avoid blood vessel damage by maintaining a catheter
641012 -                    or dilator as internal support when using a
641013 -                    peel-apart introducer.
641015 -                     ..
641016 -                c.  Avoid sheath damage by simultaneously advancing the
641017 -                    sheath and dilator as a single unit using a
641018 -                    rotational motion.
641019 -
641020 -
641022 -         ..
641023 -        Possible Complications
641024 -
641025 -        The use of a subcutaneous port provides an important means of
641026 -        venous access for critically ill patients.  However, the
641027 -        potential exists for serious complications, including the
641028 -        following:
641029 -
641030 -            1.  Air Embolism
641031 -            2.  Bleeding
641032 -            3.  Brachial Plexus Injury
641033 -            4.  Cardiac Arrhythmia
641034 -            5.  Cardiac Tamponade
641035 -            6.  Catheter or Port Erosion Through the Skin
641036 -            7.  Catheter Embolism
641037 -            8.  Catheter Occlusion
641038 -            9.  Catheter Occlusion, Damage or Breakage due to
641039 -                Compression between the Clavicle and First Rib
641040 -           10.  Catheter or port related Sepsis
641041 -           11.  Device Rotation or Extrusion
641042 -           12.  Endocarditis
641043 -           13.  Extravasation
641044 -           14.  Fibrin Sheath Formation
641045 -           15.  Hematoma
641046 -           16.  Hemothroax
641047 -           17.  Hydrothorax
641048 -           18.  Intolerance Reaction to Implanted Device
641049 -           19.  Inflammation, Necrosis, or Scarring
641050 -                of Skin Over Implant Area
641051 -           20.  Laceration of Vessels or Viscus
641052 -           21.  Perforation of Vessels or Viscus
641053 -           22.  Pneumothorax
641054 -           23.  Spontaneous Catheter Tip
641055 -                Malposition or Retraction
641056 -           24.  Thoracic Duct Injury
641057 -           25.  Thromboembolism
641058 -           26.  Vascular Thrombosis
641059 -           27.  Vessel Erosion
641060 -           28.  Risks Normally Associated with Local
641061 -                or General Anesthesia, Surgery, and
641062 -                Post-Operative Recovery
641064 -         ..
641065 -        These and other complications are well documented in medical
641066 -        literature and should be carefully considered before placing
641067 -        the port.
641069 -         ..
641070 -        Implantation Instructions
641072 -         ..
641073 -        Please read through complete implantation instructions before
641074 -        implanting port, noting "Contraindications, ref SDS 0 S77H,
641075 -        Warnings, ref SDS 0 2R5G, and Precautions" and "Possible
641076 -        Complications", ref SDS 0 4F9F sections of this manual before
641077 -        beginning procedure.
641079 -         ..
641080 -        Preventing Pinch-Off
641082 -         ..
641083 -        The risk of pinch-off syndrome can be avoided by inserting the
641084 -        catheter via the internal jugular vein (IJ).  Subclavian
641085 -        insertion of the catheter medial to the border of the first rib
641086 -        may cause catheter pinch-off, which in turn results in
641087 -        occlusion causing port system failure during power injection.
641089 -  ..
641090 - Signs of pinch off are presented earlir in the manual, per above.
641091 - ref SDS 0 7X4N
641093 -  ..
641094 - Instructions for Use continues...
641095 -
641096 -        If you choose to insert the catheter into the subclavian vein,
641097 -        it should be inserted lateral to the border of the first rib or
641098 -        at the junction with the axillary vein because such insertion
641099 -        will avoid compression of the catheter, which can cause damage
641100 -        and even severance of the catheter.  The use of image guidance
641101 -        upon insertion is strongly recommended.  A radiographic
641102 -        confirmation of catheter insertion should be made to ensure
641103 -        that the catheter is not being pinched.
641104 -
641106 -         ..
641107 -        Implantation Preparation
641108 -
641109 -
641110 -        1.  Select implantation procedure to be used.
641111 -
641112 -        2.  Select the site for port placement.
641113 -
641114 -            Note:  Port pocket site selection should allow for port
641115 -            placement in an anatomic area that provides good port
641116 -            stability, does not interfere with patient mobility, does
641117 -            not create pressure points, has not previously been
641118 -            irradiated, does not show signs of infection, and does not
641119 -            interfere with clothing.  Consider the amount of cutaneous
641120 -            tissue over the port septum, as excessive tissue will make
641121 -            access difficult.  Conversely, too thin a tissue layer over
641122 -            the port may lead to tissue erosion.  A tissue thickness of
641123 -            0.5 cm to 2 cm is appropriate.
641125 -             ..
641126 -        3.  Complete patient implant record, including length of
641127 -            catheter implanted, product reorder number and lot number.
641128 -
641129 -                 [...Millie received data showing product lot number,
641130 -                 ref SDS 0 PPRR, length of catheter is not evident in
641131 -                 the record.
641133 -             ..
641134 -        4.  Perform adequate anesthesia.
641136 -             ..
641137 -        5.  Create sterile field and open tray.
641139 -             ..
641140 -        6.  Surgically prep and drape the implantation site.
641142 -             ..
641143 -        7.  For Attachable Catheters:  Flush open-ended catheters with
641144 -            heparinized saline, through flush connector and clamp the
641145 -            catheter closed several centimeters from the distal (port)
641146 -            end.  Remember that some patients may be hypersensitive to
641147 -            heparin or suffer from heparin induced thrombocytopenia
641148 -            (HIT) and these patients must not have their port primed
641149 -            with heparinized saline.  Note:  Clamp catheter segments
641150 -            that will be cut off prior to attachment.
641151 -
641153 -         ..
641154 -        Cut-Down Procedure
641155 -
641156 -
641157 -        1.  Place patient in the Trendelenburg position with head
641158 -            turned away from the intended venipuncture site.  Use a
641159 -            cut-down incision to expose the entry vein of choice.
641161 -             ..
641162 -        2.  Perform vessel incision after vessel is isolated and
641163 -            stabilized to prevent bleeding and air aspiration.
641165 -             ..
641166 -        3.  If using a vein pick, insert its tapered end through the
641167 -            incision and advance it into the vessel.  Then slide the
641168 -            catheter tip into the grooved underside of the pick.
641170 -             ..
641171 -        4.  Advance the catheter tip into the vessel.
641173 -             ..
641174 -        5.  Withdraw the vein pick, if used.
641176 -             ..
641177 -        6.  Advance the catheter into the vessel to the desired
641178 -            infusion site.  Note:  Catheters should be positioned with
641179 -            the catheter tip at the junction of the superior vena cava
641180 -            and the right atrium.  Verify correct catheter tip
641181 -            position, using fluoroscopy, or appropriate technology.
641182 -            Warning:  Do not suture catheter to port, port stem, or
641183 -            surrounding tissue.  Any damage or constriction of catheter
641184 -            may compromise power injection performance and catheter
641185 -            integrity.
641187 -  ..
641188 - There is a schematic drawing showing position of the....
641189 -
641190 -                           a.  Vein Pick
641191 -
641192 -                           b.  Vessel (seems like another word for
641193 -                               vein)
641195 -                                ..
641196 -                           c.  Catheter
641197 -
641199 -  ..
641200 - Instructions for Use continues...
641202 -         ..
641203 -        Percutaneous Procedure:
641204 -
641205 -
641206 -        1.  Place patient in the Trendelenburg position with head
641207 -            turned away from the intended venipuncture site.
641209 -             ..
641210 -        2.  Locate desired vessel using a small gauge needle attached
641211 -            to a syringe.  Refer to the "Warnings" section covering
641212 -            catheter Pinch-off, if inserting the catheter via the
641213 -            subclavian vein.
641215 -  ..
641216 - There is an image associated with narrative for step 2, The schematic
641217 - diagrams seem to show needle syrenge penetration into a vein.
641219 -  ..
641220 - Instructions for Use continues...
641221 -
641222 -        3.  Attach introducer needle to the syringe and insert into
641223 -            vessel alongside the small gauge needle.  Remove small
641224 -            gauge needle.
641226 -             ..
641227 -        4.  Aspirate gently as the insertion is made.  If the artery is
641228 -            entered, withdraw the needle and apply manual pressure for
641229 -            several minutes.  If the pleural space is entered, withdraw
641230 -            the needle and evaluate patient for possible pneumothorax.
641232 -  ..
641233 - There is an image associated with narrative for step 4, The schematic
641234 - diagrams seem to show needle syrenge penetration into a vein.
641236 -  ..
641237 - Instructions for Use continues...
641238 -
641239 -        5.  When the vein has been entered, remove the syringe leaving
641240 -            the needle in place.  Warning:  Place a finger over the hub
641241 -            of the needle to minimize blood loss and the risk of air
641242 -            aspiration.  The risk of air aspiration is reduced by
641243 -            performing this part of the procedure with the patient
641244 -            performing the Valsalva maneuver.
641246 -             ..
641247 -        6.  If using a micropuncture set, insert the flexible end of
641248 -            the micropuncture guidewire into the needle.  Advance the
641249 -            guidewire as far as appropriate.  Verify correct
641250 -            positioning, using fluoroscopy or ultrasound.  Gently
641251 -            withdraw and remove the needle, while holding the
641252 -            micropuncture guidewire in position.  Caution:  If the
641253 -            guidewire must be withdrawn while the needle is inserted,
641254 -            remove both needle and wire as a unit to prevent the needle
641255 -            from damaging or shearing the guidewire.  Advance the small
641256 -            sheath and dilator together as a unit over the
641257 -            micropuncture guidewire, using a slight rotational motion.
641258 -            Withdraw the dilator and guidewire, leaving the
641259 -            microintroducer sheath in place.  Warning:  Place a thumb
641260 -            over the opening of the sheath to minimize blood loss and
641261 -            risk of air embolism.
641263 -  ..
641264 - There is an image associated with narrative for step 5, but actually
641265 - appears to illustrate work described in step 6.  The schematic
641266 - diagrams seem to show a micropuncture guidewire penetration into a
641267 - vein.
641269 -  ..
641270 - Instructions for Use continues...
641271 -
641272 -        7.  Straighten "J " tip of standard guidewire with tip
641273 -            straightener and insert tapered end of tip straightener
641274 -            into the needle ( or microintroducer sheath if using a
641275 -            micropuncture set).
641277 -  ..
641278 - There is an image associated with narrative for step 7.  The schematic
641279 - diagrams seem to show a micropuncture guidewire penetration into a
641280 - vein.
641282 -  ..
641283 - Instructions for Use continues...
641284 -
641285 -        8.  Remove the tip straightener and advance the standard
641286 -            guidewire into the superior vena cava.  Advance the
641287 -            guidewire as far as appropriate for the procedure.  Verify
641288 -            correct positioning, using fluoroscopy, or appropriate
641289 -            technology.
641291 -             ..
641292 -        9.  Gently withdraw and remove needle (or microintroducer
641293 -            sheath if using micropuncture set).  Caution:  If the
641294 -            guidewire must be withdrawn while the needle is inserted,
641295 -            remove both the needle and wire as a unit to help prevent
641296 -            the needle from damaging or shearing the guidewire.
641298 -  ..
641299 - There is an image associated with narrative for step 7.  The schematic
641300 - diagrams seem to show a micropuncture guidewire penetration into a
641301 - vein.
641303 -  ..
641304 - Instructions for Use continues...
641306 -         ..
641307 -        Peel-Apart Sheath Introducer Instructions
641308 -
641310 -  ..
641311 - Steps 1 -4 and step 6 have associated schematic diagrams that show the
641312 - elements being manipulated with the surgery to configure the Power
641313 - Port.
641314 -
641315 -        1.  Advance the vessel dilator and sheath introducer as a unit
641316 -            over the exposed wire using a rotational motion.  Advance
641317 -            it into the vein as a unit, leaving at least 2 cm of sheath
641318 -            exposed.  Note:  Placement may be facilitated by making a
641319 -            small incision to ease introduction of vessel dilator and
641320 -            sheath introducer.  Warning:  Avoid vessel perforation.
641322 -             ..
641323 -        2.  Release the locking mechanism and gently withdraw the
641324 -            vessel dilator and "J" wire, leaving the sheath in place.
641326 -             ..
641327 -        3.  Warning:  For non-AirGuard* introducers, hold thumb over
641328 -            exposed opening of sheath to prevent air aspiration.  The
641329 -            risk of air aspiration is reduced by performing this part
641330 -            of the procedure with the patient performing the Valsalva
641331 -            maneuver.
641333 -             ..
641334 -        4.  Insert catheter into the sheath.  Advance the catheter
641335 -            through the sheath into the vessel to the desired infusion
641336 -            site.  Catheters should be positioned with the catheter tip
641337 -            at the junction of the superior vena cava and the right
641338 -            atrium.
641340 -             ..
641341 -        5.  Verify correct catheter tip position using fluoroscopy, or
641342 -            appropriate technology.
641344 -             ..
641345 -        6.  Grasp the two handles of the peel-apart sheath and pull
641346 -            outward and upward at the same time.
641348 -             ..
641349 -        7.  Peel the sheath away from the catheter completely.  Make
641350 -            sure the catheter is not dislodged from vessel.
641351 -
641353 -         ..
641354 -        Catheter Tunneling Procedure
641355 -
641356 -
641357 -        1.  Create a subcutaneous pocket using blunt dissection.  Note:
641358 -            Do a trial placement to verify that the pocket is large
641359 -            enough to accommodate the port and that the port does not
641360 -            lie beneath the incision.
641362 -             ..
641363 -            Attachable Catheters
641365 -             ..
641366 -            Create a subcutaneous tunnel from the venous site to the
641367 -            port pocket site using tunneler or long forceps per the
641368 -            following:
641370 -                 ..
641371 -            a.  Make a small incision at the venous entry site.
641373 -                 ..
641374 -            b.  Insert tip of tunneler into the small incision.
641376 -                 ..
641377 -            c.  Form tunnel by advancing tip of tunneler from the
641378 -                venous entry site to the port pocket site.  Caution:
641379 -                Avoid inadvertent puncture of the skin or fascia with
641380 -                the tip of the tunneler.
641382 -                 ..
641383 -            d.  Remove catheter lock from the catheter.  Caution:
641384 -                Never use a catheter lock that appears cracked or
641385 -                otherwise damaged.
641387 -                 ..
641388 -            e.  Attach end of catheter onto the tunneler barb with a
641389 -                twisting motion.  Note:  Barb threads must be
641390 -                completely covered by the catheter to adequately secure
641391 -                the catheter as it is pulled through the tunnel.  A
641392 -                suture may be tied around the catheter between the
641393 -                tunneler body and the large barb to hold it more
641394 -                securely.
641396 -                 ..
641397 -            f.  Pull the tunneler through to the port pocket site while
641398 -                gently holding the catheter.  Note:  The catheter must
641399 -                not be forced.
641401 -                 ..
641402 -            g.  Place catheter lock back onto catheter, ensuring the
641403 -                black radiopaque ring or strain relief sleeve faces
641404 -                distally (toward the end of the catheter that will be
641405 -                placed centrally).
641407 -                 ..
641408 -            h.  Cut the catheter to the proper length at a 90 angle,
641409 -                allowing sufficient slack for body movement and port
641410 -                connection.  Check catheter for any damage.  If any
641411 -                damage is noted, cut damaged section off before
641412 -                connecting catheter to port.
641414 -         ..
641415 -        Connect Catheter to Port
641416 -
641417 -
641418 -        1.  Flush all air from the port body using a 10 ml syringe with
641419 -            a non-coring needle filled with heparinized saline (100 USP
641420 -            U/ml).  Insert the needle through the septum and inject the
641421 -            fluid while pointing the stem up.  Caution:  Remember that
641422 -            some patients may be hypersensitive to heparin and these
641423 -            patients must not have their port flushed with heparinized
641424 -            saline.
641426 -             ..
641427 -        2.  Cleanse all system components with irrigation solution.
641428 -            Caution:  Prior to advancing the catheter lock, ensure that
641429 -            the catheter is properly positioned.  A catheter not
641430 -            advanced to the proper region may not seat securely and
641431 -            lead to dislodgment and extravasation.  The catheter must
641432 -            be straight with no sign of kinking.  A slight pull on the
641433 -            catheter is sufficient to straighten it.  Advancing the
641434 -            catheter lock over a kinked catheter may damage the
641435 -            catheter.  Do not hold the catheter or cathlock with any
641436 -            instruments that could potentially damage either piece
641437 -            (e.g.,hemostats).
641439 -            ..
641440 -        3. Connect catheter to port:
641441 -
641442 -           a.  Align port stem with catheter.  Note:  If the catheter
641443 -               and lock are connected and then disconnected, the
641444 -               catheter end must be re-trimmed to ensure a secure
641445 -               re-connection.
641447 -  ..
641448 - There is an image associated with narrative for step a, The schematic
641449 - diagrams shows the catheter connected to the "shoulder" of the Power
641450 - Port with a "stem" fastening element; the catheter is further
641451 - connected to a "catheter lock" element.
641453 -  ..
641454 - Instructions for Use continues...
641455 -
641456 -           b.  Advance catheter over port stem to midway point.  Note:
641457 -               Advancing catheter too far along port stem could lead to
641458 -               "mushrooming" of tubing when the catheter lock is
641459 -               advanced.  Should this occur, it is advisable to stop
641460 -               advancing the catheter lock, pull the catheter back
641461 -               along the stem away from the port, and re-assemble the
641462 -               connection.
641464 -  ..
641465 - There is an image associated with narrative for step b, The schematic
641466 - diagrams shows the same elements in the diagram for step a.
641468 -  ..
641469 - Instructions for Use continues...
641470 -
641471 -           c.  Advance catheter lock straight until flush with port.
641472 -               Note:  When using the catheter lock be sure the end
641473 -               containing a colored radiopaque ring is distal to the
641474 -               port.  Catheter lock should be sufficient to secure
641475 -               catheter to port.  Bard Access Systems does not
641476 -               recommend suturing around the catheter as doing so could
641477 -               compress, kink, or damage catheter.
641479 -  ..
641480 - There is an image associated with narrative for step c, The schematic
641481 - diagrams shows the same elements in the diagram for step a, except the
641482 - Catheter Lock has been advanced to cover the stem and secure the
641483 - Catherter Lock in place with a radiopaque ring, as explained in the
641484 - narrative of step c.
641486 -  ..
641487 - Instructions for Use continues...
641489 -         ..
641490 -        Position Port and Close Incision Site
641491 -
641492 -
641493 -        1.  Place the port in the subcutaneous pocket away from the
641494 -            incision line.  This will reduce the risk of port migration
641495 -            and the possibility of it flipping over.  Secure the port
641496 -            to the underlying fascia using non-absorbable, monofilament
641497 -            sutures.  Leave sufficient slack in the catheter to permit
641498 -            slight movement, and verify that the catheter is not
641499 -            kinked.
641501 -             ..
641502 -        2.  After suturing the port in the pocket, flush the wound with
641503 -            an appropriate antibiotic solution.
641505 -             ..
641506 -        3.  Conduct flow studies on the catheter using a non-coring
641507 -            needle and 10 ml syringe to confirm that the flow is not
641508 -            obstructed, that no leak exists, and that the catheter is
641509 -            correctly positioned.
641511 -             ..
641512 -        4.  Aspirate to confirm the ability to draw blood.
641514 -  ..
641515 - Surgeon's letter to Millie reports this step was done, per above.
641516 - ref SDS 0 BF4K
641518 -  ..
641519 - Instructions for Use continues...
641520 -
641521 -        5.  Flush and lock the port system as described under heparin
641522 -            lock procedure for open-ended catheters.  Caution:
641523 -            Remember that some patients may be hypersensitive to
641524 -            heparin or suffer from heparin induced thrombocytopenia
641525 -            (HIT) and these patients must not have their port locked
641526 -            with heparinized saline.
641528 -             ..
641529 -        6.  After therapy completion, flush port per institutional
641530 -            protocol.  Close clamp while injecting last 0.5 ml of flush
641531 -            solution.
641533 -             ..
641534 -        7.  Close the incision site, so that the port does not lie
641535 -            beneath the incision.
641537 -             ..
641538 -        8.  Apply dressing according to hospital practice.
641539 -
641540 -
641541 -
641542 -
641543 -
641544 -
6416 -

SUBJECTS
Default Null Subject Account for Blank Record

6503 -
650401 -         ..
650402 -        Power Injection Procedure
650403 -
650404 -
650405 -        1.  Access the port with a PowerLoc* Safety Infusion Set.  Make
650406 -            certain that needle is long enough to be inserted fully
650407 -            within the port and that needle tip has made contact with
650408 -            the bottom of the port reservoir.  Warning:  The PowerPort*
650409 -            system is only power injectable when accessed with a
650410 -            PowerLoc* Safety Infusion Set.  Note:  Follow institutional
650411 -            protocol to verify correct catheter tip position prior to
650412 -            power injection.
650414 -  ..
650415 - Bard instruction to "make sure the needle is long eough..." presents a
650416 - vague trial and error process, ref SDS 0 JE7N, as occurred in the ER.
650417 - Can Kaiser post Millie's medical chart with notice on the correct
650418 - length of Huber needle for accessing the Power Port, so this can be
650419 - used in the Emergency Room, for CT testing, drawing blood, infusion
650420 - treatments?
650422 -                 ..
650423 -                [On 080801 Bard Field Services reports that Bard can
650424 -                only sell Huber needles for Powerloc Safety Set to
650425 -                perform CT tests with written evidence that the person
650426 -                who uses the needle for CT tests has been trained to
650427 -                implement Bard Power Injection Procedures. ref SDS 35
650428 -                OV69
650430 -  ..
650431 - The Power Port is designed with 3 palpation points and a triangular
650432 - shape to enable the clinition to find the location for inserting the
650433 - Huber needle that accesses the port, per Bard's Instructions for Use,
650434 - above. ref SDS 0 H13I  This requires experience to recognize the
650435 - insertion point through palpation (feel), since the port is covered
650436 - with skin and so invisible.
650438 -  ..
650439 - Kaiser had difficulty accessing the port catheter during treatment in
650440 - the Emergency Room Clinic on 061027, ref SDS 9 ZP43; more recently on
650441 - 080409 there were more problems accessing the port, because the needle
650442 - was not long enough. ref SDS 10 IG6S   For the previous port catheter,
650443 - Kaiser discovered that a 1" needle was effective. ref SDS 10 6R8O
650444 -
650445 -               [On 080717 UCSF Infusion Clinic nurse explains and
650446 -               demonstrates accessing Bard Power Port with Huber needle
650447 -               is fast and easy; palpation points hard to feel, but
650448 -               left hand grips triangular shape of the port "well" so
650449 -               it protudes slightly and presents a penetration target;
650450 -               a 1" high-pressure safety needle is pressed into the
650451 -               center of the target, identified by eye, until it meets
650452 -               resistance from the bottom of the port. ref SDS 30 E668
650454 -                ..
650455 -               [On 080718 Kaiser had difficulty accessing the Power
650456 -               Port causing CT test to fail with complications.
650457 -               ref SDS 32 LK3R
650459 -                ..
650460 -               [On 080724 UCSF disclosed that Huber needles injecting
650461 -               contrast medium under high pressure for CT tests have a
650462 -               higher standard of construction and safety than Huber
650463 -               needles used for blood draws and chemotherapy in the
650464 -               Oncology Infusion Clinic, ref SDS 34 OK63, this could
650465 -               mean that, if Millie's port was accessed in the Kaiser
650466 -               Oncology Infusion Clinic, and if the needle for high
650467 -               pressure injection, cited in manufacturer's Instructions
650468 -               for Use on Power Injection Procedures, reported 080708,
650469 -               ref SDS 24 JE7N, was not used, then problems doing the
650470 -               CT test on 080718 may not have been avoided simply by
650471 -               accessing the port in the Infusion Clinic. as scheduled
650472 -               on 080617 by Cal in the CT Department. ref SDS 17 DF6Y
650474 -                 ..
650475 -                [On 081017 1415 Kaiser has purchased Lifeguard Huber
650476 -                needles that meet requirements using high strength
650477 -                steel to perform pressure injection of contrast medium
650478 -                for CT tests using Bard Power Power technology.
650479 -                ref SDS 37 045H
650481 -                ..
650482 -               [On 081107 CT test team denied patient assistance for
650483 -               accurate medical history to support the 2nd attempt
650484 -               using Bard Power Port for Millie's next CT test at
650485 -               Kaiser in Walnut Creek, ref SDS 40 AN6H; Pat does not
650486 -               recall supporting Millie's CT test on 080718; does not
650487 -               recall having difficulties using the Power Port, and
650488 -               does not recall getting assistance from the patient
650489 -               assistant during the first CT test using the Power Port
650490 -               to understand relevant patient history. ref SDS 40 9J9M
650492 -                ..
650493 -               [On 090720 1437 ER refused to use Millie's Power Port
650494 -               for injecting contrast medium to perform CT test
650495 -               evaluating Millie's breathing problems caused by
650496 -               radiatoin injury, ref SDS 43 OK95; this caused access to
650497 -               fail with trauma to nurses and the patient's daughter
650498 -               seeing Millie suffer through multiple attempts to get
650499 -               adequate blood flow with conventional IV. ref SDS 43
650500 -               PQ4V
650502 -                ..
650503 -               [On 091019 0007 report that nurses in Chemotherapy
650504 -               Infusion Clinic suffered trauma because blood would not
650505 -               flow from Millie's power port, and so used conventional
650506 -               IV which caused severe pain and suffering to Millie;
650507 -               review indicated the Huber needle was only .75" which
650508 -               conflicts with 1" needle needed for adequate tip
650509 -               penetration that enables sufficient blood flow.
650510 -               ref SDS 44 0Z9P
650512 -  ..
650513 - Instructions for Use continues...
650514 -
650515 -        2.  Attach a syringe filled with sterile normal saline.
650517 -             ..
650518 -        3.  Instruct the patient to assume the position they will be in
650519 -            during the power injection procedure, before checking for
650520 -            patency.  If possible, the patient should receive power
650521 -            injection with his or her arm vertically above the shoulder
650522 -            with the palm of the hand on the face of the gantry during
650523 -            injection.  This allows for uninterrupted passage of
650524 -            injected contrast through the axillary and subclavian veins
650525 -            at the thoracic outlet.
650527 -             ..
650528 -        4.  Aspirate for adequate blood return and vigorously flush the
650529 -            port with at least 10 ml of sterile normal saline.
650530 -            Warning:  Failure to ensure patency of the catheter prior
650531 -            to power injection studies may result in port system
650532 -            failure.
650534 -             ..
650535 -        5.  Detach syringe.
650537 -             ..
650538 -        6.  Warm contrast media to body temperature.
650540 -             ..
650541 -        7.  Attach the power injection device to the PowerLoc* Safety
650542 -            Infusion Set (SIS) ensuring connection is secure.  Check
650543 -            indicated flow rate of safety infusion set and confirm CT
650544 -            settings.
650545 -
650546 -                [On 080709 letter to Kaiser primary care physicians
650547 -                requests coordination to verify CT Test department
650548 -                feels comfortable with requirements for Power Port.
650549 -                ref SDS 25 TR4Q
650551 -         ..
650552 -        Warning:  Do not exceed a 300 psi pressure limit setting, or
650553 -        the maximum flow rate setting shown below, on the power
650554 -        injection machine if power injecting through the PowerPort*
650555 -        device:
650556 -
650557 -                Powerloc SIS Guage   Size      19 Ga    20 Ga    22 Ga
650558 -                Powerloc SIS Wing    Color     Cream    Yellow   Black
650559 -                Maximum Flow Rate    Setting   5 ml/s   5 ml/s   2 ml/s
650561 -             ..
650562 -        8.  Instruct the patient to communicate immediately any pain or
650563 -            change in feeling during the injection.
650565 -             ..
650566 -        9.  Inject warmed contrast, taking care not to exceed the flow
650567 -            rate limits.  Warning:  If local pain, swelling or signs of
650568 -            extravasation are noted, the injection should be stopped
650569 -            immediately.  Warning:  Exceeding the maximum flow rate may
650570 -            result in port system failure and/or catheter tip
650571 -            displacement.
650573 -             ..
650574 -       10.  Disconnect the power injection device.
650576 -             ..
650577 -       11.  Flush the PowerPort* device with 10 ml of sterile normal
650578 -            saline.
650580 -             ..
650581 -       12.  Perform heparin lock procedure.  Remember that some
650582 -            patients may be hyper-sensitive to heparin or suffer
650583 -            heparin induced thrombocytopenia (HIT).  These patients
650584 -            must not have their port primed with heparinized saline.
650586 -             ..
650587 -       13.  After therapy completion, flush port per institutional
650588 -            protocol.  Close clamp while injecting last 0.5 ml of flush
650589 -            solution.
650591 -             ..
650592 -       14.  To deaccess PowerLoc* safety infusion set from the port,
650593 -            activate safety mechanism while withdrawing needle until
650594 -            you feel a "click" at which time the needle should be
650595 -            captured within the safety mechanism of the PowerLoc*
650596 -            safety infusion set.
650597 -
650598 -
650599 -
6506 -

SUBJECTS
Default Null Subject Account for Blank Record

6603 -
660401 -         ..
660402 -        Heparin Lock Procedure for Open-Ended Catheters
660403 -
660404 -        To help prevent clot formation and catheter blockage, implanted
660405 -        ports with open-ended catheters should be filled with sterile
660406 -        heparinized saline after each use.  If the port remains unused
660407 -        for long periods of time, the heparin lock should be changed at
660408 -        least once every four weeks.
660410 -         ..
660411 -        Caution:  Remember that some patients may be hypersensitive to
660412 -        heparin or suffer from heparin induced thrombocytopenia (HIT)
660413 -        and these patients must not have their port locked with
660414 -        heparinized saline.
660416 -         ..
660417 -        Determining Port System Volumes
660418 -
660419 -        To calculate a close approximation of port system volume, you
660420 -        will need to determine the length of catheter used for each
660421 -        individual patient. (For future reference, it will be helpful
660422 -        to record this information on the patient's chart and/or
660423 -        patient ID card.) For PowerPort* implanted port catheters,
660424 -        multiply the catheter length in cm by 0.02, then add 0.6ml for
660425 -        the port reservoir:
660427 -  ..
660428 - Was "port system volume" determined for Millie and posted to her
660429 - medical chart?
660431 -  ..
660432 - Patient identification card for the Power Port seems to show on the
660433 - back side these instructions for flushing the port after use.
660435 -  ..
660436 - Instructions for Use continues...
660437 -
660438 -        Port System Volume = Catheter length: ________ cm x 0.02 ml/cm
660439 -        + 0.6 ml = ___________ ml volume.
660441 -         ..
660442 -        If the port catheter length is not known, the following are
660443 -        recommended flushing volumes for open-ended catheters, or
660444 -        follow institutional protocol.
660446 -                         ..
660447 -                        FLUSHING VOLUMES, Open-Ended Catheters
660448 -
660449 -                PROCEDURE                      VOLUME (100 U/ml)
660450 -
660451 -                When port not in use           5 ml heparinized saline
660452 -                                               every 4 weeks
660453 -                 ..
660454 -                After each infusion of         10 ml sterile normal
660455 -                medication or TPN              saline then 5 ml
660456 -                                               heparinized saline
660457 -                 ..
660458 -                After blood withdrawal         20 ml sterile normal
660459 -                                               saline
660460 -                 ..
660461 -                After power injection of       10 ml sterile normal
660462 -                contrast media                 saline then 5 ml
660463 -                                               heparinized saline
660464 -
660466 -             ..
660467 -            [On 080710 Catherine helped Millie fill out the ID card,
660468 -            and made a copy of port flush instructions on the back for
660469 -            Millie's medical record at UCSF. ref SDS 26 YC61
660470 -
660472 -         ..
660473 -        Equipment:
660474 -
660475 -        1.  Non-coring needle
660476 -        2.  10 ml syringe filled with sterile saline
660477 -        3.  10 ml syringe filled with 5 ml heparinized saline
660478 -            (100 U/ml)
660480 -         ..
660481 -        Note: Other concentrations of heparinized saline (10 to 1000
660482 -        U/ml) have been found to be effective. Determination of
660483 -        proper concentration and volume should be based on patient's
660484 -        medical condition, laboratory tests, and prior experience.
660486 -         ..
660487 -        Procedure:
660488 -
660489 -        1.  Explain procedure to patient and prepare injection site.
660490 -
660491 -        2.  Attach a 10 ml syringe filled with sterile normal saline
660492 -            to needle.
660494 -             ..
660495 -        3.  Aseptically locate and access port.
660497 -             ..
660498 -        4.  After therapy completion, flush port per institutional
660499 -            protocol, then repeat with 5 ml 100 U/ml heparinized
660500 -            saline, or with volume calculated above.  Close clamp while
660501 -            injecting last 0.5 ml of flush solution.
660503 -         ..
660504 -        Note:  Alcohol should not be used to soak or declot
660505 -        polyurethane catheters because alcohol is known to degrade the
660506 -        polyurethane catheters over time with repeated and prolonged
660507 -        exposure.
660508 -
660509 -
660510 -
6606 -

SUBJECTS
Default Null Subject Account for Blank Record

6703 -
670401 -         ..
670402 -        References
670403 -
670404 -
670405 -        1.  Jacobs, D.  M. et. al., "Anatomical and Morphological
670406 -            Evaluation of Pacemaker Lead Compression.  PACE. 1993 Mar;
670407 -            16(1):434-444
670409 -             ..
670410 -        2.  Magney, J.  E. et. al., "Anatomical Mechanisms Explaining
670411 -            Damage to Pacemaker Leads, Defibrillator Leads, and Failure
670412 -            of Central Venous Catheters Adjacent to the
670413 -            Sternoclavicular Joint". PACE. 1993 Mar; 16(1):445-457
670415 -             ..
670416 -        3.  Hinke, D.H.; Zandt-Stastny, D.A.; Goodman, L.R.; et al.
670417 -            Pinch-off syndrome:  A complication of implantable
670418 -            subclavian venous access devices.  Radiology 177: 353-356,
670419 -            1990.
670421 -             ..
670422 -        4.  Ingle, Rebecca; Nace, Corinne. "Venous Access Devices:
670423 -            Catheter Pinch-off and Fracture." 1993, Bard Access
670424 -            Systems, Inc.
670426 -             ..
670427 -        5.  Camp-Sorrell, Dawn. "Access Device Guidelines." 2nd Ed.
670428 -            Oncology Nursing Society, 2004.
670430 -         ..
670431 -        Note:  The PowerPort* system testing included at least 36 power
670432 -        injection cycles with a PowerLoc* Safety Infusion Set and 11.8
670433 -        cP viscosity contrast solution.
670435 -         ..
670436 -        Further Reading
670437 -
670438 -        1.  See PowerPort* Implanted Port Nursing Guide and/or
670439 -            PowerPort* Implanted Port CT Guide for more details
670440 -
670441 -        2.  Bard Access Systems is proud to offer "Your Port Access
670442 -            Advantage"* patient education module for helping patients
670443 -            select their best access option.
670445 -             ..
670446 -        3.  See Bard Access Systems Sales Representative for more
670447 -            information about any of these products.
670448 -
670449 -              http://www.powerportadvantage.com
670450 -
670451 -
670452 -
6705 -

SUBJECTS
Default Null Subject Account for Blank Record

6803 -
680401 -  ..
680402 - Within the packet there is a manual with very small print...
680404 -         ..
680405 -        Air Guard Valved Introducer
680406 -
680408 -         ..
680409 -        Intended Use
680410 -
680411 -            The Air Guard Valved Introducer is indicated for use in the
680412 -            precutaneous insertion of catheters in the venous system.
680414 -  ..
680415 - This sounds like more detailed instructions for the doctor to implant
680416 - the Power Port.
680417 -
680418 -
680419 -
6805 -

SUBJECTS
Default Null Subject Account for Blank Record

6903 -
690401 -  ..
690402 - Within the packet there is a manual with very small print...
690404 -         ..
690405 -        Power Port
690406 -        Patient Guide
690407 -
690408 -        This is a 16 page document that replicates a lot of content in
690409 -        the Instructions for Use document, per above. ref SDS 0 D67I
690410 -
690411 -        Table of Contents
690413 -         ..
690414 -        INTRODUCTION
690415 -        Feel the New Standard of Care*.............. 3, ref SDS 0 EO35
690417 -         ..
690418 -        Presenting Your PowerPort* Implanted Port... 4, ref SDS 0 EO7J
690419 -        How Your PowerPort Device Is Used........... 5, ref SDS 0 EO4K
690421 -         ..
690422 -        IDENTIFICATION
690423 -        How to Know You Have a PowerPort
690424 -        Implanted Port.............................. 6, ref SDS 0 EO6O
690425 -        Identify Yourself!.......................... 6, ref SDS 0 3S4P
690426 -        Feel the Difference!........................ 7, ref SDS 0 EP6H
690428 -         ..
690429 -        ACCESS
690430 -        How Your PowerPort Device Is Accessed....... 8, ref SDS 0 EP8P
690432 -         ..
690433 -        HEPARIN LOCK
690434 -        About Heparin Locks......................... 9, ref SDS 0 EP9J
690436 -         ..
690437 -        POWER INJECTION/CECT SCANS
690438 -        What to Expect During Power Injection
690439 -        for CECT Scans............................. 10, ref SDS 0 EP5K
690440 -        About Power-Injected CECT Scans............ 10, ref SDS 0 EP5K
690441 -        What Your Clinician Should Know............ 11, ref SDS 0 EQ4J
690443 -         ..
690444 -        Q & A
690445 -        Common Questions and Answers............... 12, ref SDS 0 EQ5I
690447 -         ..
690448 -        TELL YOUR CLINICIAN
690449 -        Tell Your Clinician, You've Got the Power!............... 15
690451 -         ..
690452 -        PATIENT CHECKLIST
690453 -        Patient Checklist........................................ 16
690454 -
690455 -
690457 -         ..
690458 -        INTRODUCTION
690460 -         ..
690461 -        Feel the New Standard of Care*.
690463 -         ..
690464 -        Your doctor has prescribed the PowerPort* Implanted Port for
690465 -        your IV therapy treatments.  This new kind of implanted port
690466 -        offers the unique ability to provide access for power-injected
690467 -        Contrast-Enhanced Computed Tomography (CECT) scans.
690468 -        Power-injected CECT scans produce superior images of your body
690469 -        to help the medical team better manage your treatment.  With
690470 -        your PowerPort Implanted Port, you'll be able to receive IV
690471 -        therapy and CECT scans without having to undergo repeated
690472 -        needlesticks in your peripheral (arm or wrist) veins.
690474 -         ..
690475 -        Please read all of the information contained in this Patient
690476 -        Guide.  It gives you the knowledge to understand and feel
690477 -        comfortable with your PowerPort Implanted Port.  Just as your
690478 -        PowerPort device is new to you, it may not yet be familiar to
690479 -        all clinicians involved in your care.  That's because the
690480 -        PowerPort Implanted Port is a new technology designed to
690481 -        accommodate powerinjected CECT scans.  The patient-specific
690482 -        information contained in this Guide gives you the power to
690483 -        inform clinicians about your PowerPort device, so that you can
690484 -        take advantage of power-injected CECT scans and avoid
690485 -        unnecessary needlesticks.
690487 -         ..
690488 -        You should also carry your PowerPort device Patient
690489 -        Identification Card with you to show to clinicians whenever
690490 -        your port is accessed.  It informs clinicians that you have a
690491 -        PowerPort Implanted Port and provides a summary of important
690492 -        information they should know about the port.  If you need
690493 -        additional information about your PowerPort device, please talk
690494 -        with your doctor or nurse.
690495 -
690497 -         ..
690498 -        Presenting Your PowerPort* Implanted Port
690500 -         ..
690501 -        Your PowerPort Implanted Port is a small device placed
690502 -        completely beneath your skin in a short procedure.  It is a
690503 -        cylinder with a hollow space inside that is sealed by a soft
690504 -        top.  The PowerPort device connects to a small, flexible tube
690505 -        called a catheter that is inserted inside one of the large
690506 -        central veins that deliver blood to your heart.  When a special
690507 -        needle is put into the soft top of the PowerPort device, it
690508 -        creates "access" to your bloodstream, meaning that medications
690509 -        and fluids can be given and blood samples withdrawn.
690511 -  ..
690512 - There is a schematic diagram showing the Power Port implanted
690513 - seemingly in the skin, rather beneath the skin.  There is a catheter
690514 - cable connected in the side of the Power Port and running horizontal
690515 - within the skin, making a u-like turn and penetrating a vein beneath
690516 - the skin and continuing within the vein for what appears several
690517 - inches, perhaps 4 inches.  The image shows a human hand holding a
690518 - PowerLoc Safety Infusion Set, which has been called a "Huber" needle,
690519 - and the image shows the hand poised to press the needle into the Power
690520 - Port.
690522 -  ..
690523 - Power Port Patient Guide continues...
690525 -         ..
690526 -        How Your PowerPort* Device Is Used
690527 -
690528 -        Your PowerPort Implanted Port allows clinicians to easily
690529 -        deliver medications or fluids or withdraw blood samples without
690530 -        having to repeatedly stick your peripheral veins directly with
690531 -        a needle.  This makes it more comfortable for you.  Because the
690532 -        PowerPort device places medications into the large central
690533 -        veins instead of the small peripheral veins, the medications
690534 -        mix more thoroughly in the blood, diluting them so they are
690535 -        less harmful to your vascular system.
690537 -         ..
690538 -        The PowerPort Implanted Port is used with the PowerLoc* Safety
690539 -        Infusion Set.  This enables fluids called contrast agents to be
690540 -        power-injected (delivered at a high rate) into your
690541 -        bloodstream.  As a result, tissues in your body show up more
690542 -        clearly, making it easier for your doctors to monitor the
690543 -        status of your condition.  Power-injected CECT scans are safe,
690544 -        non-invasive procedures that provide important information for
690545 -        disease diagnosis and treatment.
690546 -
690548 -         ..
690549 -        IDENTIFICATION
690551 -         ..
690552 -        How to Know You Have a PowerPort* Implanted Port
690554 -         ..
690555 -        There are several ways that you and your clinicians can
690556 -        recognize that you have a PowerPort device instead of a
690557 -        traditional type of implanted port.
690558 -
690560 -         ..
690561 -        Identify Yourself!
690562 -
690563 -            1.  Key Ring Card
690564 -            2.  Identification Card
690565 -            3.  Bracelet
690567 -         ..
690568 -        Upon receiving your PowerPort Implanted Port, you are provided
690569 -        with an identification card, bracelet and key ring card
690570 -        identifying you as a patient with a PowerPort device.  Carry
690571 -        your PowerPort device Patient Identification Card with you at
690572 -        all times.  Show it to the clinician beforehand whenever your
690573 -        port is accessed for a procedure.  You may wear the bracelet or
690574 -        carry the key ring as convenient reminders that you have a
690575 -        PowerPort Implanted Port.
690577 -  ..
690578 - Millie's Power Port identification card shows...
690579 -
690580 -                 REF............
690584 -                  ..
690585 -                 LOT............
690589 -  ..
690590 - Power Port Patient Guide continues...
690591 -
690592 -        In addition, if you have received a PowerPort Implanted Port,
690593 -        your patient chart should show a PowerPort device record
690594 -        sticker noting this fact.
690596 -  ..
690597 - Does Millie's medical chart show she has a Power Port?
690599 -  ..
690600 - The primary care physician noted in the medical chart for the meeting
690601 - on 080627 planning item #4 to Place Power Port. ref SDS 21 CO3H
690603 -  ..
690604 - Power Port Patient Guide continues...
690605 -
690606 -        Feel the Difference!
690607 -
690608 -        Your PowerPort* Implanted Port has a unique shape and design
690609 -        that distinguishes it from traditional ports.  Trained
690610 -        clinicians can recognize these distinctive features under your
690611 -        skin by feeling for them with their fingers, a process called
690612 -        palpation.  A trained clinician palpating the sides of your
690613 -        PowerPort device should recognize its unique triangle shape.  A
690614 -        trained clinician palpating the top of your PowerPort device
690615 -        should be able to feel three bumps called Palpation Points that
690616 -        are arranged like a triangle on the port.
690618 -         ..
690619 -        Ask your doctor or nurse to help you feel the difference by
690620 -        showing you how to palpate your new PowerPort Implanted Port.
690621 -
690623 -         ..
690624 -        ACCESS
690626 -         ..
690627 -        How Your PowerPort* Device Is Accessed
690629 -         ..
690630 -        Your clinicians will use the PowerPort Implanted Port whenever
690631 -        they need to infuse medications or fluids into your body or
690632 -        withdraw samples of your blood.  To do this, they will first
690633 -        access the PowerPort device by inserting a special needle into
690634 -        the soft top of the device.  Ask the clinician about what to
690635 -        expect in your own procedure.
690636 -
690638 -         ..
690639 -        HEPARIN LOCKS
690640 -
690641 -        About Heparin Locks
690643 -         ..
690644 -        Sometimes when blood clots, it can block the catheter,
690645 -        preventing medications and fluids from flowing through it.
690646 -        However, blood will not clot when it is thinned with a
690647 -        medication called heparin.  To help prevent clots from forming,
690648 -        implanted ports are typically filled with sterile heparinized
690649 -        saline after each use.  This process is called a heparin lock.
690650 -        If your PowerPort Implanted Port will not be used for long
690651 -        periods of time, the clinician will typically change the
690652 -        heparin lock every four weeks.  If you have been diagnosed as
690653 -        being allergic to heparin or as having heparin induced
690654 -        thrombocytopenia (HIT), it is important to remind the clinician
690655 -        of this fact anytime your PowerPort device is accessed.
690656 -
690658 -         ..
690659 -        POWER INJECTION/CECT SCANS
690660 -
690661 -        What to Expect During
690662 -        Power Injection for CECT Scans
690663 -
690664 -        About Power-Injected CECT Scans
690666 -         ..
690667 -        Contrast-Enhanced Computed Tomography (CECT) scans are simple,
690668 -        safe and non-invasive procedures that provide quick and
690669 -        accurate diagnostic information to help your medical team
690670 -        manage your care.  These scans are many times more sensitive
690671 -        than conventional x-rays.  Radiologists can distinguish small
690672 -        differences in your soft tissues that may not be detected with
690673 -        x-rays.
690675 -         ..
690676 -        Before performing a CECT scan, the radiology team will inject a
690677 -        contrast agent, which is a special fluid that acts like a dye,
690678 -        into your body to help produce clearer pictures during the CECT
690679 -        scan procedure.  For best results, the contrast agent is
690680 -        infused at a high rate into your bloodstream.  This process is
690681 -        called power injection.  Your PowerPort* Implanted Port used
690682 -        with the PowerLoc* Safety Infusion Set has the unique ability
690683 -        to allow clinicians to perform powerinjected CECT scans without
690684 -        having to make a needlestick in your arm or wrist veins.
690686 -         ..
690687 -        What Your Clinician Should Know
690689 -         ..
690690 -        Always show your PowerPort device Patient Identification Card
690691 -        to clinicians who perform your CECT scan.  It informs them that
690692 -        you have a PowerPort Implanted Port.
690693 -
690695 -         ..
690696 -        Common Questions and Answers
690697 -
690698 -
690699 -        1.  How do I take care of my PowerPort* Implanted Port?
690701 -             ..
690702 -            During the first few days after receiving the PowerPort
690703 -            Implanted Port, avoid heavy exertion and follow the
690704 -            instructions your doctor or nurse has given you for taking
690705 -            care of the small incision.  Once the incision has healed,
690706 -            the beauty of your PowerPort Implanted Port is that you do
690707 -            not have to take any special care of it, and you can resume
690708 -            normal daily activities.
690710 -             ..
690711 -        2.  Will the PowerPort Implanted Port affect my daily
690712 -            activities?
690714 -             ..
690715 -            Once the incision heals following implantation, you should
690716 -            be able to return to your normal daily activities, such as
690717 -            bathing, swimming or jogging.  Ask your doctor or nurse
690718 -            about specific activities and the appropriate time to
690719 -            resume them.
690721 -             ..
690722 -        3.  Will I need to wear a bandage
690723 -            over the PowerPort Implanted Port?
690725 -             ..
690726 -            A bandage will be required until your incision heals.
690727 -            After the incision has healed, a bandage is not required
690728 -            when the PowerPort device is not being used.  If you are
690729 -            receiving continuous infusion of fluids, a bandage may be
690730 -            applied to stabilize and protect the needle while it is in
690731 -            place.
690733 -             ..
690734 -        4.  Do I have to stop wearing certain types of clothing?
690735 -
690736 -            Ask your doctor or nurse because the answer will depend on
690737 -            where your PowerPort device is placed.
690739 -             ..
690740 -        5.  Who pays for the PowerPort* Implanted Port?
690741 -
690742 -            Insurance policies vary, so check with your insurance
690743 -            company first.
690745 -             ..
690746 -        6.  Will the PowerPort Implanted Port
690747 -            activate security alarms?
690749 -             ..
690750 -            Security systems most likely will not detect the small
690751 -            amount of metal in the device. If it does occur, simply
690752 -            show your PowerPort device Patient Identification Card.
690754 -             ..
690755 -        7.  How long will I have my PowerPort Implanted Port?
690756 -
690757 -            The PowerPort Implanted Port can stay in place for
690758 -            as long as your doctor determines that you need it.
690760 -             ..
690761 -        8.  Will my PowerPort device need to be accessed when not in
690762 -            use?
690763 -
690764 -            Yes. It will need to be flushed every 4 weeks.
690766 -             ..
690767 -        9.  Can the PowerPort device be removed if I no longer need it?
690769 -             ..
690770 -            Yes.  When no longer needed, the PowerPort Implanted Port
690771 -            can be removed in a simple procedure similar to the one
690772 -            used to implant it.
690774 -             ..
690775 -       10.  Is the PowerPort device safe with CT and MRI?
690776 -
690777 -            Yes.  The materials used in the PowerPort/PowerLoc system
690778 -            are latex-free, non-ferromagnetic and safe with CT, CECT
690779 -            and magnetic resonance imaging (MRI) procedures and all
690780 -            injectable fluids used with these procedures.
690782 -  ..
690783 - What about PET scan tests?
690785 -  ..
690786 - Power Port Patient Guide continues...
690787 -
690788 -       11.  What if the clinician has not seen a patient with a
690789 -            PowerPort device before?
690790 -
690791 -            The PowerPort Implanted Port is a new technology.  It may
690792 -            not yet be familiar to all clinicians involved in your
690793 -            care.  Always show clinicians your PowerPort device Patient
690794 -            Identification Card, especially if your PowerPort device
690795 -            will be accessed for power-injected CECT scans.  Your
690796 -            PowerPort device Patient Identification Card contains a
690797 -            summary of important information for the clinician.  If
690798 -            clinicians need more information, they may contact the Bard
690799 -            Access Systems Clinical Information Hotline at
690800 -            800-443-3385.
690801 -
690803 -         ..
690804 -        TELL YOUR CLINICIAN
690805 -
690806 -        Tell Your Clinician You've Got the Power!
690808 -         ..
690809 -        As a new patient with a PowerPort Implanted Port, you've got
690810 -        the power to take an active role in your treatment.  The best
690811 -        way you can be involved is to share information and concerns
690812 -        with your clinicians.  Speak up!  Ask questions about anything
690813 -        that concerns you or if you notice anything that seems unusual.
690815 -         ..
690816 -        What to Report to Your Clinician
690818 -         ..
690819 -        Here are some important things to tell your clinician:
690820 -
690821 -        1.  You have a PowerPort Implanted Port.
690822 -
690823 -        2.  If you notice any redness or inflammation at the site of
690824 -            your PowerPort Implanted Port after the incision heals.
690826 -             ..
690827 -        3.  If you have a fever.
690829 -             ..
690830 -        4.  If you have allergies to any medications or materials.
690832 -             ..
690833 -        5.  If you have an allergy to heparin.
690835 -             ..
690836 -        6.  If you have heparin induced thrombocytopenia (HIT)
690838 -             ..
690839 -        7.  If you have ever been prescribed anticoagulant
690840 -            (bloodthinning) medications such as heparin or warfarin.
690842 -             ..
690843 -        8.  If you have previously been treated with radiation.
690845 -             ..
690846 -        9.  If you have ever been diagnosed with lung disease.
690848 -             ..
690849 -       10.  If you have ever been diagnosed with, or treated for,
690850 -            venous thrombosis.
690852 -             ..
690853 -       11.  If you have ever been diagnosed with any tissue
690854 -            diseases or suffered from tissue erosion.
690856 -             ..
690857 -       12.  If you have ever been diagnosed or tested for "pinchoff"
690858 -            syndrome.
690860 -             ..
690861 -       13.  If other clinicians have ever had difficulty withdrawing
690862 -            blood or infusing fluids through your implanted port,
690863 -            including whether other clinicians have ever required you
690864 -            to change position to allow blood or fluid to flow.
690865 -
690867 -         ..
690868 -        PATIENT CHECKLIST
690869 -
690870 -
690871 -        1.  The PowerPort* device is a new kind of implanted port that
690872 -            provides access for both IV therapy treatments and
690873 -            power-injected Contrast-Enhanced Computed Tomography (CECT)
690874 -            scans.
690876 -             ..
690877 -        2.  Upon receiving your PowerPort device, you will also receive
690878 -            an Identification Card, Bracelet and Key Ring Card that
690879 -            identify you as a patient with a PowerPort Implanted Port.
690881 -             ..
690882 -        3.  Carry your Identification Card at all times.  You may also
690883 -            wear the bracelet or carry the key ring as convenient
690884 -            reminders to tell your medical professionals that you have
690885 -            a PowerPort Implanted Port.
690887 -             ..
690888 -        4.  Show your Identification Card to the clinician whenever
690889 -            your port is accessed for a procedure, especially
690890 -            power-injected CECT scans.
690892 -             ..
690893 -        5.  The Identification Card contains important information for
690894 -            the clinician.  If clinicians need more information, they
690895 -            may contact the Bard Access Systems Clinical Information
690896 -            Hotline at 800-443-3385.
690898 -             ..
690899 -        6.  Speak up!  Share information with clinicians and ask about
690900 -            anything that concerns or seems unusual to you.
690901 -
690902 -
690903 -
690904 -
690905 -
690906 -
690907 -
690908 -
690909 -
690910 -
690911 -
690912 -
690913 -
690914 -
690915 -
690916 -
690917 -
690918 -
690919 -
6910 -