BEUDAMED
    FDA Adverse Event Other Summary report: N

    BACT/ALERT BPA AND BPN CULTURE BOTTLES

    MDR report key: 948532 · Received November 6, 2007

    Report

    Report Number
    3002769706-2007-00006
    Event Type
    Other
    Date Received
    November 6, 2007
    Date of Event
    October 16, 2007
    Report Date
    November 5, 2007
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT# 1016995, EXP DATE: 05/31/08. THE MEDICAL DIRECTOR OF THE LAB WHERE THE EVENT OCCURRED DOES NOT ALLEGE ANY DEFECT OR FAILURE ON THE PART OF BACT/ALERT OR THE BPN OR BPA BOTTLES USED IN TESTING AND BELIEVES THE ORGANISM WAS SO LOW IN THE DONATED UNIT THAT NO VIABLE ORGANISMS WERE CAPTURED IN THE 4-8 ML/BOTTLE SAMPLE. PACKAGE INSERTS FOR BOTH BPA AND BPN BOTTLES STATE "AFTER CULTURE BOTTLE HAVE BEEN LOADED INTO THE INSTRUMENT, THEY SHOULD REMAIN THERE FOR FIVE TO SEVEN DAYS OR UNTIL DESIGNATED POSITIVE, OR UNTIL THE PLATELET UNIT REACHES ITS EXPIRATION DATE." THE PACKAGE INSERT ALSO CAUTIONS THAT "A REPORT OF 'NEGATIVE' SHOULD NOT BE INTERPRETED AS MEANING THAT THE ORIGINAL PRODUCT IS STERILE. THE NEGATIVE STATUS COULD BE DUE TO UNDER-INOCULATION OF THE BOTTLE, NO ORGANISMS PRESENT IN THE INOCULUM, THE NUMBER OF ORGANISMS WERE TOO SMALL FOR DETECTION, OR A CULTURE BOTTLE/MEDIUM THAT DOES NOT SUPPORT THE GROWTH OF THE ORGANISM."

    Description of Event or Problem · 1

    TWO PATIENTS SUFFERED SEPTIC TRANSFUSION REACTIONS FOLLOWING CONTAMINATED PLATELET TRANSFUSIONS. BACTALERT BPN AND BPA WERE NEGATIVE-TO-DATE ON DAY 4 AT THE TIME OF THE TRANSFUSION. THE APHERESIS DONATION WAS SPLIT AND TRANSFUSED INTO TWO PATIENTS. PATIENT 1 EXPERIENCED TRANSFUSION REACTION THE EVENING OF THE TRANSFUSION. BLOOD CULTURES FROM PATIENT AND CULTURES FROM THE PLATELET BAGS WERE PERFORMED. METHICILLIN-RESISTANT S AUREUS WAS RECOVERED FROM BOTH THE PATIENT AND THE PLATELET BAGS. TWO DAYS AFTER THE TRANSFUSION, SEPTIC TRANSFUSION REACTION WAS REPORTED IN THE SECOND PATIENT. THE BPN AND BPA BOTTLES WERE STILL UNDER TEST AND NEGATIVE-TO-DATE (DAY 6). WHEN THE BPN AND BPA BOTTLES REACHED MAXIMUM TEST TIME, THEY WERE STILL NEGATIVE. THE BOTTLES WERE SENT TO THE MICROBIOLOGY LAB FOR TESTING; THE GRAM-STAINS SHOWED NO ORGANISMS AND THE SUBCULTURES HAD NO GROWTH. BOTH PATIENTS WHO HAD REACTIONS RECOVERED AND WERE DISCHARGED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT BPA AND BPN CULTURE BOTTLES MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 1017756

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention