THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
S U M M A R Y
DIARY: August 1, 2008 08:31 AM Friday;
Bard called about support for CT tests using Power Port technology.
2...Product Defect or Product Damage Due to Improper Use
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Bard Coordinating Plans Strategy with Kiser for Next CT Test Avoid
0403 - ..
0404 - Summary/Objective
040501 - Follow up ref SDS 8 CW9U, ref SDS 7 0000.
040507 - ..
0408 - Progress
040901 - Shelly called this morning, following up her telephone message
040902 - yesterday asking Millie to get product identification for the Huber
040903 - needle used at Kaiser for the CT test on 080718.
040905 - ..
040906 - Shelly's telephone number...
040908 - 801 595 7140
040910 - ..
040911 - She confirmed this morning that Bard needs the specification of the
040912 - Huber needle Kaiser used for Millie's CT test on 080718.
040914 - ..
040915 - The needle could have been below requirements for high pressure
040916 - injections, and/or it could have been too short. ref SDS 7 WI7G
040918 - ..
040919 - Shelly explained that Bard can only sell Huber needles to medical
040920 - hospitals with evidence on file that care providers, who use the
040921 - needles for CT tests, have been trained to correctly implement "Power
040922 - Injection Procedures" specified in Bard's manual on "Instructions for
040923 - Use," received on 080708. ref SDS 2 JE7N Requirements for suitably
040924 - trained clinician to use the Huber needle are specified in Bard
040925 - Instructions for Use. ref SDS 2 6U5K
040927 - [...below Julie, Bard Kaiser field representative, offers to
040928 - attend Millie's next CT test to consult and train Kaiser's
040929 - staff, and help avoid further problems. ref SDS 0 OW41
040931 - ..
040932 - Shelly feels Kaiser's records will show the Huber needle used for
040933 - Millie's CT test, required for both procurement and inventory
040934 - processes, and for quality control, will show the name of nurse or
040935 - other care provider who has been listed by Kaiser as trained to
040936 - implement Bard Manufactuerer's "Instructions for Use" to perform
040937 - "Power Injection Procedures," and in accordance with local protocol.
040939 - ..
040940 - Shelly advised that...
040942 - Ben Giglioti
040943 - 858 353 4273
040945 - ...can assist Millie working with Kaiser to review problems that
040946 - occurred using the Bard Power Port for the CT test on 080718,
040947 - ref SDS 7 0001, and to be prepared for the next CT test.
040951 - ..
040952 - Product Defect or Product Damage Due to Improper Use
040954 - Shelly explained that Bard's first concern is to determine if their
040955 - products are defective, either the Power Port or the PowerLoc Safety
040956 - Set (Huber needle), and/or if extravasation that occurred during the
040957 - failed test may have damaged the port, creating risks for the next
040958 - test. The port may work okay to draw blood and inject chemotherapy
040959 - drugs, but may not support power injection of contrast medium, cited
040960 - on 080718. ref SDS 7 458M This is a particular concern in light of
040961 - the record showing questions were raised during the test on 080718
040962 - about converting units of measure for the rate of injection flow.
040963 - ref SDS 7 NM5V
040965 - ..
040966 - Shelly said that thumbing through her records, she feels...
040968 - Julie Mayor
040969 - 310 710 8164
040971 - ...represents Bard with Kaiser in Walnut Creek, and would be a better
040972 - person to follow up on Millie's situation.
040974 - ..
040975 - Shelly put the call on hold, while she tried contacting Julie.
040979 - ..
0412 - 0843
041301 - Shelly came back online.
041303 - She just talked to Julie about Millie's CT test. She has not yet
041304 - submitted the record of work on 080718 for Julie to learn the scope of
041305 - problems. ref SDS 7 0001 Shelly related that Julie has initially
041306 - proposed Millie contact...
041308 - Lynn Nearney
041309 - Director of Education
041310 - Kaiser Walnut Creek
041311 - 925 295 4872
041313 - ...about getting support for training in time for Millie's next CT
041314 - test in 6 weeks.
041316 - ..
041317 - Discussed advantage of Bard contacting Lynn and others at Kaiser about
041318 - Bard support to ensure the next CT test goes more smoothly.
041320 - ..
041321 - Shelly suggested calling Julie and enlisting her assistance, since the
041322 - sales people have good contacts and know the ropes at Kaiser. They
041323 - also do the training, and so will have background on what needs to be
041324 - done to get everyone up to speed for Millie's next test.
041329 - ..
0416 - 0849
041701 - Called Julie.
041703 - Julie has been working with Kaiser in Walnut Creek for 18 months or
041704 - so.
041706 - ..
041707 - About a year ago Julie provided training on using the Huber needle to
041708 - access the Bard Power Port for CT tests.
041710 - ..
041711 - Julie was later told that Kaiser in Walnut Creek adopted a policy not
041712 - to use Power Ports for CT tests, and that she should stop contacting
041713 - Kaiser about selling Huber needles and providing training, until
041714 - Kaiser changed to a policy of using Power Ports for CT tests. This
041715 - aligns with Ike's report on 080711 that the Kaiser CT Department in
041716 - Walnut Creek does not have experience using Power Ports for CT tests.
041717 - ref SDS 4 PP7O
041719 - ..
041720 - Millie's letter to the medical team on 080709 explained plans Kaiser
041721 - proposed for first CT test at Kaiser in Walnut Creek with Power Port
041722 - technology, ref SDS 3 TR5P, and discussed opportunity to improve the
041723 - work from experience. ref SDS 3 VK5I On 080716 Kaiser called and
041724 - changed the protocol from relying on experienced staff in the Infusion
041725 - Clinic to access the port, and from leaving the Huber needle in place
041726 - from treatment the day before at UCSF, ref SDS 6 UW5N, to instead
041727 - relying on people in the CT Department. ref SDS 6 AN6G
041729 - ..
041730 - Julie has maintained contacts with Lynn Nearney and Paula Vannicola at
041731 - Kaiser. Julie seemed further to recognize Nora and Kathi, as people
041732 - she has contacted at Kaiser in Walnut Creek about using Power Ports
041733 - for CT tests. She feels there is strong support for adopting this
041734 - Bard technology to improve CT test practices that avoid excessive
041735 - needle punctures which injure patients. This aligns with Millie's
041736 - experience on 080425 that showed urgent requirements for a solution
041737 - that avoids injury to patients getting CT tests. ref SDS 1 FP6F
041739 - ..
041740 - [On 080804 Julie talked with Paula and with Lynn, and possibly
041741 - others at Kaiser in Walnut Creek; initial feedback is for Bard
041742 - not be involved in the Millie matter. ref SDS 9 OV5I
041744 - ..
041745 - Julie only heard about Millie's case today from Shelly by telephone,
041746 - per above. ref SDS 0 RV6L She has not read the record of work on
041747 - 080718. ref SDS 7 0001 After talking to Shelly this morning, Julie
041748 - called for Lynn, and for Paula to discuss strategy on helping Kaiser
041749 - with technology transfer implementing Bard Power Ports.
041751 - ..
041752 - Julie mentioned that, besides using an injection needle that does not
041753 - meet specifications for high pressure, or is too short, another common
041754 - problem is failing to flush the port and drawing some blood prior to
041755 - starting the injection. Nurses in the Infusion Clinic who access
041756 - ports regularly for blood draws and chemotherapy treatments are highly
041757 - experienced and confident about these steps. People who only use
041758 - ports occassionally, don't have enough experience to have confidence
041759 - doing the work, and able to recognize minor details essential for
041760 - effective use.
041762 - ..
041763 - Julie said she would be willing to personnally attend Millie's next CT
041764 - test to consult during the port access and injection procedures. This
041765 - can be part of the training required for Bard to release for sale
041766 - Huber needles used to access Power Ports performing CT test injections
041767 - of contrast medium, noted by Shelly earlier this morning, per above.
041768 - ref SDS 0 OV69
041770 - [On 081108 Steve asks how the test went at Kaiser using the
041771 - Bard Power Port; explains Bard could not support the Power Port
041772 - customer on 081107, proposed by Bard on 080801, ref SDS 0 OW41,
041773 - requested by customer on 081028, and reminded on 081106,
041774 - because Bard was busy attending a class to support future
041775 - customers for Bard radiographic technology. ref SDS 13 4P4K
041777 - ..
041778 - This aligns with planning discussed with Kaiser the week before
041779 - Millie's CT test, during meeting at Kaiser on 080711. ref SDS 4 JR6T
041781 - [On 080911 Angela at CT Department with Kaiser in Oakland
041782 - asked for Millie's Power Port ID card; after learning Millie
041783 - has the Bard Power Port, she advised that training by Bard
041784 - personnel a day or so earlier resolved issues, ref SDS 10
041785 - JX60; and so did not need the Power Port ID card to check
041786 - flow rates and flushing instructions, and did not need to
041787 - change settings on CT test equipment; this resulted in
041788 - successful CT test using Bard Power Port. ref SDS 10 LK3R
041790 - ..
041791 - [On 080912 Steve, District Manager for Bard, disclosed that he
041792 - sent a representative to the Kaiser CT Department in Oakland a
041793 - few days before Millie's test to provide training and
041794 - orientation. ref SDS 11 C65I
041796 - ..
041797 - [On 081107 Dennis, CT Department supervisor at Kaiser in Walnut
041798 - Creek, was not available to manage use of new technology for
041799 - the 2nd time to correct problems the first time, ref SDS 12
041800 - VR4L; Pat who had worked on Millie's CT test using the Power
041801 - Port for the 1st time, and had scheduled the 2nd test, did not
041802 - remember Millie nor that the test would use Bard Power Port
041803 - technology, ref SDS 12 MX4L; Steve, District Manager for Bard,
041804 - who had talked to Dennis and said Kaiser was "good to go" using
041805 - the Bard Power Port for the CT test, and Julie, who had offered
041806 - to be on-site for the test, did not have time to support the
041807 - 2nd attempt using Bard equipment, which had failed on the 1st
041808 - attempt, ref SDS 12 2F6S; nobody seemed to be prepared for
041809 - applying manufacturer's instructions; communication to
041810 - collaborate on coordinating the work failed by relying on
041811 - memory of very talented, dedicated people under stress with
041812 - limited time. ref SDS 12 2F32
041814 - ..
041815 - [On 081108 Steve asks how the test went at Kaiser using the
041816 - Bard Power Port; explains Bard could not support the Power Port
041817 - customer on 081107, proposed by Bard on 080108, ref SDS 0 OW41,
041818 - requested by customer on 081028, and reminded on 081106,
041819 - because Bard was busy attending a class to support future
041820 - customers for Bard radiographic technology. ref SDS 13 4P4K
041822 - ..
041823 - [On 081111 Millie notifies medical team with copy to Bard that
041824 - CT test was completed on 081107, ref SDS 14 WP8G, Kaiser trying
041825 - to improve the work to smooth out the rough edges using Bard
041826 - Power Port technology. ref SDS 14 2F3R
041828 - ..
041829 - [On 081111 Steve District Manager asks how Bard can help Kaiser
041830 - smooth out the "rough edges" on technology transfer using the
041831 - Bard Power Port. ref SDS 15 4Q3H
041833 - ..
041834 - Julie feels the first step is for her to understand the record on
041835 - Millie's first attempt using the Bard Power Port that failed 2 weeks
041836 - ago on 080718. After she reads through what happened during the test,
041837 - she will follow up her initial calls to Lynn and Paula. Julie will
041838 - then call Millie to discuss strategies and planning for the next CT
041839 - test.
041841 - ..
041842 - A major question is how the Kaiser CT department can get trained and
041843 - acquire sufficient skill from experience to use Power Ports with Huber
041844 - needles, if the Infusion Clinic, who has nurses who do this work
041845 - everyday cannot cross-train for a number of months the technologists
041846 - in the CT Department. Ike wanted a nurse from the Infusion Clinic to
041847 - attend Millie's first CT test, reported on 080711. ref SDS 4 JQ98 On
041848 - 080715 the doctor refused this support. ref SDS 5 PQ6P
041850 - [On 080912 Steve, District Manager for Bard, disclosed that he
041851 - sent a representative to the Kaiser CT Department in Oakland a
041852 - few days before Millie's test to provide training and
041853 - orientation. ref SDS 11 C65I
041857 - ..
0421 - 0901
042201 - Millie submitted ref DIT 1 0001 to Julie...
042203 - 1. Subject: Bard Review Power Port Failure Kaiser CT Test 080718
042204 - Date: Fri, 01 Aug 2008 09:03:52 -0700
042212 - ..
042213 - 3. Here is the record on Millie's CT test on July 18th; it is a
042214 - little long, but it may provide clues on what went wrong, and
042215 - how we can help position Kaiser to succeed for the next test in
042216 - 6 weeks. ref SDS 7 0001
042218 - [On 080804 Julie lost the letter sent today; it was
042219 - resubmitted so she can review the record of the test on
042220 - 080718. ref SDS 9 4R50
042222 - ..
042223 - 4. A week earlier, we talked to Paula in the Infusion Clinic, and
042224 - she suggested we talk to the CT Department to make sure
042225 - everything was set up for using the Power Port for the first
042226 - time. Here is that discussion. ref SDS 4 RF6K
042228 - ..
042229 - 5. Your background working with Kaiser in Walnut Creek the past
042230 - year to get training on using the Power Port provides the
042231 - ballast needed to aid transformation for this excellent new
042232 - technology.
042234 - ..
042235 - 6. I am copying Shelly to let her know we are making progress, and
042236 - copying Paula to let her know as well. I will see Paula in a
042237 - few minutes at the Infusion Clinic, and discuss this as well.
042239 - ..
042240 - 7. I am also copying my doctor and his assistant, Arlette, to let
042241 - them know there is progress toward getting ready for the next
042242 - CT test in 6 weeks.
042244 - ..
042245 - 8. Thanks for following up.
042250 - ..
0425 - 1543
042601 - Called Julie and left message asking about results of Julie's research
042602 - today. ref SDS 0 PY5V