CONTACTS 

SUBJECTS
Bard Coordinating Plans Strategy with  Kiser for Next CT Test Avoid

0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up ref SDS 7 0000.
040502 -
040503 -
040504 -
040505 -
040506 -
040508 -  ..
0406 -
0407 -
0408 - Progress
0409 -
040901 - Talked to Julie.
040902 -
040903 - Julie has talked to Paula and to Lynn at Kaiser, per telecon on
040904 - 080801. ref SDS 7 OV65  She may have talked to others, perhaps in the
040905 - CT Department.
040906 -
040907 -        Julie Mayor
040908 -        310 710 8164
040910 -  ..
040911 - Julie said that part of her job as the manufacturer's representative
040912 - is to help hospitals review protocols when problems occur using Bard
040913 - products.  Comprehensive review investigates for product defects, and
040914 - issues related to training, and implementation of manufacturer's
040915 - instructions.
040917 -  ..
040918 - For example, there could be a product defect that enables Millie's
040919 - Power Port to handle blood draws and chemotherpay infusion treatments,
040920 - but cannot handle power injection of contrast medium for CT tests.
040921 - This needs to be discovred and corrected, if necessary.
040923 -  ..
040924 - Similarly, there could have been a product defect in the Huber needle,
040925 - which Bard calls a "Powerloc Safety Infusion Set," shown by Bard
040926 - "Instructions for Use" in the section on Power Injection Procedures,
040927 - reviewed on 080708, ref SDS 2 JE7N,
040929 -  ..
040930 - Julie was told that Kaiser in Walnut Creek has not changed the policy
040931 - on using Power Ports for CT tests.  At this time, Kaiser in Walnut
040932 - Creek is not using Power Ports for CT tests.  Julie was further told
040933 - that Bard should not respond to patient support for improving the work
040934 - to avoid problems on future CT tests, and that Julie should not offer
040935 - assistance to Kaiser in Walnut Creek for discovering why the test
040936 - using the Power Port on 080718 failed, and what can be done to fix
040937 - problems in order to be successful on the next CT test.
040938 -
040939 -        [On 080807 discuss with UCSF doing Millie's CT tests with the
040940 -        Power Port. ref SDS 9 U14W
040942 -         ..
040943 -        [On 080811 Paula at Kaiser Infusion Clinic investigating
040944 -        solutions to support CT Department for Millie's next test
040945 -        OA 080912; issue has been elevated, but no progress from
040946 -        management reported at this time, ref SDS 10 LD3H; there
040947 -        seems to be at least three (3) solutions. ref SDS 10 CW3O
040948 -        Paula coordinating with primary care physician about
040949 -        contacting Kaiser Oakland to perform Millie's next CT test.
040950 -        ref SDS 10 DE79
040952 -  ..
040953 - This seems to be shaping up as a battle between surgery, which is only
040954 - implanting Power Ports that support CT tests, and the CT department
040955 - that does not want to use the Power Port because, in the beginning it
040956 - seems more complicated to connect to a Huber needle than to a
040957 - conventional IV.  On 080801, Julie listed some common issues that
040958 - arise and require care using Huber needles for power injection of
040959 - contrast medium. ref SDS 7 OW43
040961 -  ..
040962 - Julie indicated that Kaiser in Hayward and in Santa Clara are both
040963 - doing CT tests with the Power Port.
040965 -  ..
040966 - Julie will find out if Kaiser in San Francisco does CT tests with
040967 - Power Ports.  This would be convenient for Millie who gets treatment
040968 - every Thursday around the corner from Kaiser in San Francisco.
040969 -
040970 -        [On 080805 Steve advised that Kaiser in San Francisco does not
040971 -        use Power Port for CT tests, but Kaiser in Oakland has been
040972 -        using the Power Port technology for over a year. ref SDS 0 5U7G
040974 -         ..
040975 -        [On 080811 Paula at Kaiser Infusion Clinic investigating
040976 -        solutions to support CT Department for Millie's next test
040977 -        OA 080912; issue has been elevated, but no progress from
040978 -        management reported at this time, ref SDS 10 LD3H; there
040979 -        seems to be at least three (3) solutions. ref SDS 10 CW3O
040980 -        Paula coordinating with primary care physician about
040981 -        contacting Kaiser Oakland to perform Millie's next CT test.
040982 -        ref SDS 10 DE79
040984 -         ..
040985 -        [On 080811 commend Bard for excellent customer support helping
040986 -        find a Kaiser facility that can use the Power Port for the CT
040987 -        test, ref SDS 10 P95U, confirmed by Paula that Kaiser Oakland
040988 -        does CT tests with a Bard Power Port. ref SDS 10 L465
040990 -  ..
040991 - We need a task to verify the Power Port and/or the needle used for
040992 - Millie's test was not defective.
040993 -
040994 -        [...below, Bard District Manager, Steve, advises that Bard has
040995 -        a protocol to review test failures for possible product
040996 -        defects. ref SDS 0 4R40
040998 -         ..
040999 -        [...below, Millie's letter to Bard confirms understanding Bard
041000 -        has manufacturer's quality control protocol to investigate
041001 -        failed CT tests to verify Power Port and Huber needles not
041002 -        defective for future tests. ref SDS 0 CM5P
041004 -         ..
041005 -        [On 080811 letter to Kaiser with copy to Bard asks about
041006 -        verifying suitability of Bard Power Port after extravasation
041007 -        problems. ref SDS 10 P44W
041009 -         ..
041010 -        [On 080905 Millie notified Bard Kaiser will perform another CT
041011 -        test using the same Bard Power Port device which failed for the
041012 -        test on 080718, and asking if Bard is satisfied the record
041013 -        presents no product defect risks for Millie. ref SDS 13 Y76X
041015 -         ..
041016 -        [On 080911 Kaiser in Oakland successfully performed a CT test
041017 -        using Millie's Bard Power Port with a Lifeguard Safety Infusion
041018 -        Set Huber needle. ref SDS 14 LK3R
041020 -  ..
041021 - We reviewed the Huber needle product specification received from UCSF
041022 - on 080724. ref SDS 6 MV7Y
041024 -  ..
041025 - Julie seemed to say that Lifeguard safety needle does not support
041026 - Bard requirements.
041028 -  ..
041029 - This needs clarification to verify that if UCSF accesses Millie's port
041030 - for the next CT test, they use a needle with "high pressure tubing,"
041031 - noted in documentation received from UCSF on 080724. ref SDS 6 N762
041033 -  ..
041034 - Actually, the product specification states expressly that Lifeguard
041035 - safety needles are designed for power injection of contrast medium for
041036 - CT tests. ref SDS 6 N79U
041038 -         ..
041039 -        [On 080911 Kaiser in Oakland successfully performed a CT test
041040 -        using Millie's Bard Power Port with a Lifeguard Safety Infusion
041041 -        Set Huber needle. ref SDS 14 LK3R
041043 -  ..
041044 - Julie wants to read through the record of Millie's test on 080718, so
041045 - she has a good understanding of events, and then notify her boss
041046 - asking about next steps to support the customer.  Julie said she
041047 - cannot find the letter last week on this matter.  Suggested she look
041048 - on 080801.  Julie could not find the letter in her Microsoft Outlook
041049 - email program.  She said they some feature that automatically deletes
041050 - some letters.
041052 -  ..
041053 - Resubmitted the letter on 080801 to Julie. ref SDS 7 OW7X
041055 -  ..
041056 - While we talked, Julie said she has received the letter on 080801
041057 - again and can now make a thorough review.  Julie then said she found
041058 - the original in another Microsoft Outlook folder which she didn't
041059 - recognize, and had forgot she had created, and so has two copies of
041060 - the same letter.  She will delete one to avoid further confusion.
041061 -
041062 -
041063 -
041065 -  ..
0411 -
0412 -
0413 - 0933
0414 -
041401 - Julie called back.
041403 -  ..
041404 - Julie has discussed Millie's case with her boss...
041405 -
041406 -           Steve Sigl
041407 -           925 200 6419
041408 -           Bard
041409 -           District Manager
041410 -           steve.sigl@crbard.com
041412 -  ..
041413 - Julie indicated that Steve is now handling Millie's case at the
041414 - District level.
041416 -  ..
041417 - Thanked Julie for assistance working with Bard to support Kaiser using
041418 - Millie's Power Port for CT tests.
041419 -
041421 -  ..
0415 -
0416 -
0417 - 0936
0418 -
041801 - Called and left message for Steve.
041802 -
041804 -  ..
0419 -
0420 -
0421 - 0942
0422 -
042201 - Steve called back.  He is the director of sales for the West Coast
042202 - region, where Julie works.
042204 -  ..
042205 - Steve requested copies of the record on Millie's CT test performed at
042206 - Kaiser on 080718 so that Bard can respond appropriately.  He feels
042207 - Bard Field Services Department should take the lead on quality control
042208 - issues, including product defects, and application of manufacturer's
042209 - instructions, which may relate to difficulties encountered using the
042210 - Power Port for Millie's CT test at Kaiser on 080718. ref SDS 5 0001
042212 -  ..
042213 - We reviewed the discussion with Shelly in Field Services last week on
042214 - 080801, ref SDS 7 OV5I, recommending that the Sales Department has the
042215 - most direct contact with Kaiser, and so should be contacted by the
042216 - patient to help Kaiser develop a work plan for recovering from the
042217 - problems on 080718, and to be prepared for Millie's next CT test in 6
042218 - weeks.
042220 -  ..
042221 - Steve seemed to say that Bard Field Services has a protocol for
042222 - responding to reports of problems using Power Ports and Huber needles,
042223 - which is discussed above on review required after failure of CT test
042224 - using Bard Power Port. ref SDS 0 MS4T  He feels the sales department
042225 - can support Field Services, with contact information at Kaiser, and
042226 - background on training, noted by Julie in the call on 080801.
042227 - ref SDS 7 OV9H
042228 -
042229 -        [...below, Millie's letter to Bard confirms understanding Bard
042230 -        has manufacturer's quality control protocol to investigate
042231 -        failed CT tests to verify Power Port and Huber needles not
042232 -        defective for future tests. ref SDS 0 CM5P
042234 -         ..
042235 -        [On 080811 letter to medical team with copy to Bard asking
042236 -        about investigating suitability of Power Port for next test.
042237 -        ref SDS 10 P44W
042239 -         ..
042240 -        [On 080905 Millie notified Bard Kaiser will perform another CT
042241 -        test using the same Bard Power Port device which failed for the
042242 -        test on 080718, and asking if Bard is satisfied the record
042243 -        presents no product defect risks for Millie. ref SDS 13 Y76X
042245 -         ..
042246 -        [On 080911 Angela at CT Department with Kaiser in Oakland
042247 -        asked for Millie's Power Port ID card; after learning Millie
042248 -        has the Bard Power Port, she advised that training by Bard
042249 -        personnel a day or so earlier resolved issues, ref SDS 14
042250 -        JX60; and so did not need the Power Port ID card to check
042251 -        flow rates and flushing instructions, and did not need to
042252 -        change settings on CT test equipment; this resulted in
042253 -        successful CT test using Bard Power Port. ref SDS 14 LK3R
042255 -  ..
042256 - Steve indicated that Kaiser in Oakland has been doing CT tests with
042257 - the Power Port for over a year.  Evidently, Kaiser in San Francisco
042258 - near UCSF is not yet implementing Power Ports for CT tests.
042260 -  ..
042261 - This supplements notice on 080801 that Kaiser in Santa Clara and in
042262 - Hayward use Power Port technology for CT tests. ref SDS 0 MS9U
042263 -
042264 -        [On 080807 discuss with UCSF doing Millie's CT tests with the
042265 -        Power Port. ref SDS 9 U14W
042266 -
042267 -        [On 080811 Paula at Kaiser Infusion Clinic investigating
042268 -        solutions to support CT Department for Millie's next test OA
042269 -        080912; issue has been elevated, but no progress from
042270 -        management reported at this time, ref SDS 10 LD3H; there seems
042271 -        to be at least three (3) solutions. ref SDS 10 CW3O  Paula
042272 -        coordinating with primary care physician about contacting
042273 -        Kaiser Oakland to perform Millie's next CT test. ref SDS 10
042274 -        DE79
042276 -         ..
042277 -        [On 080811 Kaiser reports Oakland office has experience
042278 -        doing CT tests with Power Port and Huber needle technology,
042279 -        ref SDS 10 L465; schedule Millie's next CT test on 080911
042280 -        at Kaiser in Oakland. ref SDS 10 L549
042282 -         ..
042283 -        [On 080811 commend Bard for excellent customer support helping
042284 -        find a Kaiser facility that can use the Power Port for the CT
042285 -        test. ref SDS 10 P95U
042287 -         ..
042288 -        [On 080822 Kaiser notifies Millie that CT test using Power Port
042289 -        and Huber needle technology is scheduled for Kaiser in Oakland
042290 -        on 080911. ref SDS 11 N66E
042292 -         ..
042293 -        [On 080826 Kaiser CT Department in Walnut Creek called and
042294 -        advised that the Kaiser CT Department in Oakland sent
042295 -        Millie's case back to the CT Department at Kaiser in Walnut
042296 -        Creek. ref SDS 12 VG6N
042297 -
042298 -
042299 -
042300 -
042301 -
042302 -
042303 -
042305 -  ..
0424 -
0425 -
0426 - 1213
0427 -
042701 - Ben Giloti called.  He was initially presented by Shelly on 080801 for
042702 - following up with Kaiser on Millie's CT test issues. ref SDS 7 4G6O
042704 -  ..
042705 - Ben was not aware that Julie has been discussing this matter.
042707 -  ..
042708 - Advised Ben that Steve indicated a call earlier today that he is now
042709 - handling the matter at the sales department level for Bard, per above.
042710 - ref SDS 0 025B
042712 -  ..
042713 - Ben indicated that Kaiser in San Francisco is not using Power Ports
042714 - for CT tests.  This aligns with Steve's comments earlier today, per
042715 - above. ref SDS 0 5U7G
042717 -  ..
042718 - UCSF is one of his accounts.
042720 -  ..
042721 - He believes that nurses in the Infusion Clinic access the port and the
042722 - CT technologists then perform the test.  There may be a transition
042723 - period where CT Technologists cross-train in the Infusion Clinic on
042724 - the Huber needle accessing the port, and/or nurses from the Infusion
042725 - Clinic go to the CT Department to assist the Techs learning to access
042726 - the Power Port with the Huber needle.  Different hospitals handle
042727 - training and technology transfer differently.
042729 -  ..
042730 - Ben seemed to indicate patients at Kaiser in Oakland get their port
042731 - accessed in the Infusion Clinic, then go to the CT Department, but
042732 - that some CT Technologists may be starting to access the port.  The
042733 - key point is that some period of cross-training and support seems
042734 - essential by professionals in the Infusion Clinic who access Power
042735 - Ports every day to help people who only do this work occassionally in
042736 - the CT Department.
042738 -  ..
042739 - Ben mentioned something about "certification."  Upon discussion he was
042740 - unsure about whether this is an actual state government regulatory
042741 - requirement, or just local facility terminology.  On 080711 Ike in the
042742 - CT Department at Kaiser in Walnut Creek mentioned something about
042743 - "certification." ref SDS 3 JQ55  On 080718 there was no evident
042744 - showing of "certification" for Millie's CT test. ref SDS 5 A25R
042745 -
042746 -
042748 -  ..
0428 -
0429 -
0430 - 1353
0431 -
043101 - Letter to Steve submitting background on Millie's CT test at
043102 - Kaiser...
043103 -
043104 -    1.  Subject: Bard Review Power Port Failure Kaiser CT Test 080718
043105 -        Date: Mon, 04 Aug 2008 15:54:47 -0700
043113 -         ..
043114 -    3.  In discussion this morning, you requested a copy of the record
043115 -        showing problems that occurred using the Bard Power Port for my
043116 -        CT test at Kaiser in Walnut Creek, CA on 080718.  The record is
043117 -        lengthy to facilitate trouble shooting.  Please read the full
043118 -        record for context. ref SDS 5 0000
043120 -         ..
043121 -    4.  My current concern is to get things lined up for the next test
043122 -        now in about 6 weeks.  This requires review of issues presented
043123 -        beginning at line B003. ref SDS 5 WI7G
043125 -         ..
043126 -    5.  I was pleased to hear from your discussion with Rod that Bard
043127 -        has a protocol for product problem review.  This should allow
043128 -        timely, careful analysis to support Kaiser going forward.
043129 -        Naturally, I want to ensure there is no product defect
043130 -        involved.
043131 -
043132 -            [On 080805 Steve forwarded this letter to Shelly in Field
043133 -            Assurance, ref SDS 8 5N8J; he plans to read the record to
043134 -            assist Bard training to avoid problems that occurred with
043135 -            Millie's CT test using the Bard Power Port and Powerloc
043136 -            Safety Set. ref SDS 8 8487
043138 -             ..
043139 -            [On 080811 letter to medical team with copy to Bard asking
043140 -            about investigating suitability of Power Port for next
043141 -            test. ref SDS 10 P44W
043143 -             ..
043144 -            [On 080905 Millie notified Bard Kaiser will perform another
043145 -            CT test using the same Bard Power Port device which failed
043146 -            for the test on 080718, and asking if Bard is satisfied the
043147 -            record presents no product defect risks for Millie.
043148 -            ref SDS 13 Y76X
043150 -         ..
043151 -    6.  Your plan today to refer the matter back to Field Services can
043152 -        provide feedback from sales.  Last week on 080801, Shelly in
043153 -        Field Services said to contact Julie about getting the ball
043154 -        rolling to find out what happened toward developing a recovery
043155 -        plan, reported on 080801. ref SDS 7 OV5I
043157 -         ..
043158 -    7.  Julie has been terrific making initial inquiries, and
043159 -        explaining background on training and related issues.
043161 -         ..
043162 -    8.  Your assistance is greatly appreciated.
043170 -         ..
043171 -   11.  PS.  Below is background on Bard review beginning with my
043172 -        initial letter to Bard on 080719.
043173 -
043174 -
043175 -
043176 -
043177 -
043178 -
043179 -
043180 -
043181 -
043182 -
043183 -
043184 -
0432 -