BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT 3D

    MDR report key: 1577564 · Received January 8, 2010

    Report

    Report Number
    MW5014287
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 8, 2010
    Manufacturer
    BIOMERIEUX
    Product Code
    JTA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY UTILIZES THE BACT/ALERT BACTERIAL IMPURITIES LIMIT TEST FOR THE BACTERIAL SCREENING OF ALL APHERESIS PLATELET PRODUCTS. THIS SCREENING PROCESS CONTINUES THROUGHOUT THE -5 DAY- EXPIRATION TIMEFRAME OF EACH PRODUCT, AND THESE UNITS ARE RELEASED TO HOSPITAL CONSIGNEES DURING THE MONITORING PERIOD. IF THERE IS A SCREENING POSITIVE ON A PRODUCT THAT HAS BEEN RELEASED TO A HOSPITAL, A SYSTEM ALARM NOTIFIES A STAFF WHO IMMEDIATELY CONTACT THE CONSIGNEE AND ADVISE THEM NOT TO TRANSFUSE THE UNIT. ON TWO OCCASIONS, WITHIN A FOUR MONTH PERIOD, THE CONTROLLER HAS FAILED ON ONE DEVICE USED BY THE FACILITY. AS A RESULT, THE SCREENING BOTTLES ARE NEITHER ROTATED WITHIN THE DEVICE NOR MONITORED FOR POSITIVE RESULTS. THERE IS NO ALARM TO SIGNAL THIS FAILURE MODE AND THUS, THE FAILURE MAY EXCEED THE MFR'S TIMEFRAME SPECS FOR BOTTLE ROTATION/MONITORING. AS A CONSEQUENCE, FACILITY LOSES THE ABILITY TO IMMEDIATELY IDENTIFY POTENTIAL POSITIVE SCREENING RESULTS AND MONITOR THE TEST STATUS OF UNITS ASSOCIATED WITH THE FAILED DEVICE. ALTHOUGH THE MFR HAS STATED THAT THIS TYPE OF FAILURE IS A "RARE" EVENT, WE HAVE ADVISED HIM THAT IT IS UNACCEPTABLE AND A SYSTEM IMPROVEMENT MUST BE IMPLEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT 3D SDP BACTERIAL IMPURITIES LIMIT TEST JTA BIOMERIEUX BACT/ALERT 3D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other