BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALYX INSTRUMENT, COMPONENT COLLECTION SYSTEM

    MDR report key: 2123076 · Received October 29, 2008

    Report

    Report Number
    3004548776-2008-00001
    Event Type
    Injury
    Date Received
    October 29, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    GKT
    PMA / PMN Number
    BK080024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A FENWAL FIELD SERVICE REP DOWNLOADED THE ELECTRONIC LOG FILES OF THE (B)(6) 2008 PROCEDURE FROM THE ALYX INSTRUMENT. THERE WERE NO ALARMS DURING THE PROCEDURE, AND THE PROCEDURE RESULTED IN TWO UNITS OF RED BLOOD CELL (RBC) PRODUCT. ALL SAFETY CONTROLS OF THE INSTRUMENT WERE FUNCTIONING APPROPRIATELY. THE PROCEDURE RAN FOR 59 MINS, AND ENCOUNTERED NO LOW BLOOD FLOW CONDITIONS. THIS REVIEW CONFIRMS THAT THE INSTRUMENT FUNCTIONED AS INTENDED FOR THIS PROCEDURE. DATA COLLECTED BY THE INSTRUMENT SUPPORTS THAT THE DONOR'S ESTIMATED HEMATOCRIT (HCT) TO HAVE APPROX 18% AT THE BEGINNING OF THE DONATION. FENWAL REACHED THIS CONCLUSION BASED ON THE TOTAL BLOOD VOLUME PROCESSED, AND THE TOTAL PACKED RBC PRODUCT COLLECTED. USING TYPICAL ESTIMATES OF 3% HCT DECREASE PER UNIT OF BLOOD DONATED, THE DONOR WOULD THEN HAVE HAD AN ENDING HCT VALUE OF 12% (2 UNITS DONATED = 6% HCT DROP, USING TYPICAL ESTIMATES). BASED ON THE INFO REC'D FROM THE INSTRUMENT AND THE REPORTING CUSTOMER, IF THE DONOR HEMATOCRIT WAS 40%, AS ENTERED BY THE OPERATOR, A VOLUME OF 360ML OF ABSOLUTE RBCS WOULD NOT HAVE BEEN COLLECTED IN THE FINAL PRODUCT. THE SEPARATION OF WHOLE BLOOD INTO PACKED RBC AND PLASMA WAS UNDER CONTROL THROUGHOUT THE PROCEDURE, AND THERE WAS NO UNEXPECTED SPILL OF RED BLOOD CELLS INTO THE PLASMA CONTAINER. THE VOLUME OF RED BLOOD CELLS THAT WOULD HAVE BEEN MISSED IN THE COLLECTION PROCESS WOULD HAVE TRIGGERED MULTIPLE CONTROLS, AS WELL AS VISIBLE IDENTIFICATION OF RED CELLS IN THE PLASMA BAG BY THE OPERATOR. THIS DID NOT OCCUR. ADD'L INVESTIGATION: INFO ACQUIRED FROM FENWAL MEDICAL DIRECTOR'S F/U WITH REPORTING BLOOD CENTER'S MEDICAL DIRECTOR: THE REPORTING CENTER'S MEDICAL DIRECTOR SPOKE WITH THE DONOR'S PERSONNEL PHYSICIAN WHO PROVIDED THE MEDICAL HISTORY INFO OF A GASTRIC BY-PASS SURGERY AND HISTORY OF ANEMIA, WITH A KNOWN LEVEL OF 8 G/DL. AT THE TIME OF HER BLOOD DONATION, WHEN TESTED AT THE REPORTING BLOOD CENTER IT WAS BELIEVED THE DONOR HAD A HEMOGLOBIN CONCENTRATION OF 13.4, PER AN INSTRUMENT USED BY THE REPORTING BLOOD CENTER (A MINIMUM HEMOGLOBIN VALUE OF 13.3 IS REQUIRED TO DONATE). PER FENWAL MEDICAL DIRECTOR THE DONOR'S ACTUAL PRE-DONATION HEMATOCRIT CAN BE ESTIMATED AS FOLLOWS. IF WE ASSUME THAT 360 ML ABSOLUTE OF RBCS WERE COLLECTED (EXCLUSIVE OF THE VOLUME USED FOR BLOOD SAMPLES) WE CAN ESTIMATE THE PRE-DONATION HEMATOCRIT BY THE RELATIONSHIP: ABSOLUTE RBCS COLLECTED DIVIDED BY TOTAL BLOOD VOLUME PROCESSED = PRE-DONATION HEMATOCRIT. THIS IS EQUAL TO 360/2156 OR A HEMATOCRIT PRIOR TO DONATION OF APPROX 17%. SINCE ONE GRAM OF HEMOGLOBIN IS EQUIVALENT TO APPROX HEMATOCRIT POINTS, THIS WOULD BE EQUIVALENT TO HEMOGLOBIN CONCENTRATION OF 17/3 OR 5.7 GRAMS PER DL. BASED UPON THE ABOVE, IT WOULD APPEAR THAT THE PRE-DONATION HEMOGLOBIN CONCENTRATION DETERMINATION PERFORMED PRIOR TO DONATION WAS INCORRECT AND THAT THE PERSON SHOULD NOT HAVE SERVED AS A DONOR DUE TO THE UNDERLYING ANEMIC CONDITION. THERE IS NO EVIDENCE OF INSTRUMENT MALFUNCTION ASSOCIATED WITH THIS DONATION PROCEDURE. UNLESS INFO IS REC'D THAT MIGHT OTHERWISE CHANGE THE CONCLUSION OF THIS EVENT, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6), 2008, A CUSTOMER REPORTED RECEIVING INFO FROM A DONOR THAT SHE HAD REQUIRED A TRANSFUSION OF 4 UNITS OF RBCS DUE TO A HEMOGLOBIN TEST RESULT READING OF 4 G/DL, SIX DAYS FOLLOWING HER DOUBLE RED CELL DONATION. THE CENTER REPORTED THAT THIS DONOR HAD DONATED DOUBLE RED CELLS AT THEIR CENTER ON (B)(6), 2008. HER HEMOGLOBIN LEVEL ON THE DAY OF THE PROCEDURE WAS DOCUMENTED TO HAVE BEEN 13.4, AT THE TIME OF DONATION. THE DONOR TOLD THE CENTER SHE HAD CALLED HER PERSONAL PHYSICIAN THE EVENING OF (B)(6) 2008, STATING SHE WAS FEELING TIRED AND 'NOT RIGHT'. HE ADVISED HER TO INCREASE HER PROTEIN CONSUMPTION AND DRINK EXTRA FLUIDS. AS SHE CONTINUED TO FEEL TIRED SHE WENT TO SEE HER PERSONAL PHYSICIAN ON (B)(6) 2008. HE ORDERED A CBC, AND BASED ON THE LOW HEMOGLOBIN LEVEL, TREATED HER WITH THE TRANSFUSION OF RBCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALYX INSTRUMENT, COMPONENT COLLECTION SYSTEM ALYX APHERESIS INSTRUMENT GKT BAXTER HEALTHCARE 4R5707

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention ALYX RED CELL DISPOSABLE KIT: (B)(4),| LOT#: H08G01021