BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT ALERT BPA

    MDR report key: 579009 · Received March 4, 2005

    Report

    Report Number
    3002769706-2005-00007
    Event Type
    Death
    Date Received
    March 4, 2005
    Date of Event
    December 1, 2004
    Report Date
    March 4, 2005
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED A TRANSFUSION OF APHERESIS PLATELETS FOR THROMBOCYTOPENIA AFTER CORONARY ARTERY BYPASS SURGERY. BEFORE TRANSFUSION, PLATELETS FROM THE UNIT BAG WERE TESTED FRO BACTERIAL CONTAMINATION USING ONE BACT ALERT BPA BOTTLE IN THE BACT ALERT INSTRUMENT. THE BACT ALERT BPA BOTTLE IS A STANDARD AEROBIC BLOOD CULTURE BOTTLE USED TO MONITOR MICROBIAL (BACTERIA AND FUNGI) GROWTH. THE BOTTLE WAS FOUND TO BE NEGATIVE AFTER 5 DAYS OF INCUBATION. ON DAY 5, THE PLATELET COLLECTION WAS USED IN THE TRANSFER. APPROXIMATELY 1 HOUR AFTER TRANSFUSION, THE PT HAD SHORTNESS OF BREATH, CHILLS, AND A TEMPERATURE OF 102.9 AND BECAME HYPOTENTIVE. THE PT SUBSEQUENTLY HAD MULTIPLE THROMBOTIC EVENTS AND DIED 27 HOURS LATER. S. LUGDUNENSIS WAS CULTURED FROM THE PT'S BLOOD AND THE LEFTOVER PLATELET BAG. THE BLOOD CULTURE BOTTLE, AFTER 10 DAYS OF INCLUDBATION, WAS SENT TO CDC AND RETESTED. NO ORGANISM AT CDC WERE IDENTIFIED BY CULTURE OR BY GRAM STAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT ALERT BPA MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death