BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT/ALERT - BPA BOTTLE

    MDR report key: 856840 · Received May 25, 2007

    Report

    Report Number
    1950204-2007-00003
    Event Type
    Death
    Date Received
    May 25, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 9, 2007
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLING PROTOCOL FOLLOWED BY BLOOD CENTER (BC) DOES NOT COMPLY WITH THE PLATELET SPECIMEN COLLECTION PROCEDURES DETAILED IN THE BACT/ALERT BPA (BPA) PACKAGE INSERT. THE BPA PACKAGE INSERTS READS "THE PLATELET SPECIMEN SHOULD BE TAKEN AT LEAST 24 HOURS AFTER COLLECTION TO ALLOW FOR NATURAL PROLIFERATION IN THE PLATELET PRODUCT". AS NOTED IN THE PACKAGE INSERT, THE PLATELET SPECIMEN SHOULD BE STORED AT ROOM TEMPERATURE (15-30 DEGREE C) DURING THE 24 HOURS POST-COLLECTION. ALTHOUGH THE FBC'S SAMPLING PROTOCOL DOES NOT FOLLOW THE BPA PACKAGE INSERT PROCEDURES, IT HAS BEEN APPROVED BY FDA ACCORDING TO FBC'S MEDICAL DIRECTOR. FBC BELIEVES THAT INCUBATION AT 37 DEGREE C IS BETTER THAN STORING AT ROOM TEMPERATURE FOR ORGANISM PROLIFERATION. SINCE PLATELETS MUST REMAIN AT ROOM TEMPERATURE FOR TRANSFUSION, THE ENTIRE PLATELET UNIT CANNOT BE INCUBATED AT 37 DEGREE C. FOR THIS REASON, FBC RETRIEVED AN ALIQUOT AFTER SAMPLE COLLECTION TO INCUBATE AT 37 DEGREE C FOR 24 HOURS AND THEN INOCULATED THE BPA BOTTLE. THIS POSES AN ISSUE BECAUSE THE NUMBER OF ORGANISMS IN THE ALIQUOT IS NOT REPRESENTATIVE OF THE NUMBER OF ORGANISMS IN THE ENTIRE PLATELET UNIT. SINCE THE NUMBER OF ORGANISMS IN DONOR PLATELET UNITS ARE TYPICALLY LOW, AN ALIQUOT IS NOT LIKELY TO CONTAIN A VIABLE NUMBER OF ORGANISMS EVEN THOUGH THE NON-INCUBATED, TRANSFUSED PORTION UNIT MAY CONTAIN A VIABLE NUMBER OF ORGANISMS FOR DETECTION. ALSO, CANCER CTR TESTED THE PLATELET UNIT USING BPA (PER THE PACKAGE INSERT INSTRUCTIONS) AFTER THE PT WAS DIAGNOSED WITH "SUSPECTED BACTEREMIA" AND REC'D A POSITIVE RESULT. THE POSITIVE RESULT OBTAINED BY CANCER CTR SHOWS THAT THE BPA BOTTLE, WHEN USED AS INSTRUCTED, DETECTS ORGANISMS PROPERLY. THE NEGATIVE RESULT OBTAINED BY BC WAS DUE TO THEIR SAMPLING METHODOLOGY DIFFERING FROM THE BACT/ALERT BPA PACKAGE INSERT INSTRUCTIONS. BIOMERIEUX OBTAINED BACK-UP DISKS FROM BC TO REVIEW THE PERFORMANCE OF THE INSTRUMENT AND WAS UNABLE TO DETECT ANY ERRORS ASSOCIATED WITH THIS NEGATIVE RESULT.

    Description of Event or Problem · 1

    IN 2007, BLOOD CENTER COLLECTED WHOLE BLOOD DERIVED DONOR PLATELETS. ON THE SAME DAY, AN ALIQUOT OF THE PLATELET UNIT WAS INCUBATED AT 37 DEGREE C FOR 24 HOURS POST-COLLECTION. THE FOLLOWING DAY, A BACT/ALERT BPA BOTTLE (LOT 10105093, EXP. 12/12/07) WAS INOCULATED WITH THE INCUBATED ALIQUOT. FOUR DAYS LATER, A TRANSFUSED PATIENT WAS REPORTED TO HAVE "SUSPECTED BACTEREMIA". THE PATIENT DEVELOPED A POST-TRANSFUSION INFECTION WITH GROUP D STREP RESULTING IN THE PT'S DEATH. THE DATE OF THE PT'S DEATH IS UNKNOWN AT THIS TIME. THE TRANSFUSION OCCURRED AT CANCER AND RESEARCH CENTER USING PLATELETS FROM BLOOD CENTER, BUT THE EXACT DATE OF TRANSFUSION IS UNKNOWN AT THIS TIME. ACCORDING TO BLOOD CENTER, THE BPA BOTTLE UNDERWENT 5 DAY TESTING AND GENERATED A NEGATIVE RESULT. THE BOTTLE WAS DISCARDED SO ADDITIONAL TESTING IS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT - BPA BOTTLE MICROBIAL DETECTION SYSTEM LTT BIOMERIEUX, INC. 279018 1015093

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death