BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT SIII

    MDR report key: 1242974 · Received November 17, 2008

    Report

    Report Number
    1242974
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    OXYGENATOR OCCLUDED BY CLOT. ECMO SPECIALIST FAILED TO RECOGNIZE THE OCCLUSION. THIS REPORT IS BEING SUBMITTED AS AN FYI ITEM SO OTHER USERS WILL BE AWARE THAT EXPOSURE OF PATIENT AND STAFF IS A POSSIBLE OUTCOME OF THIS TYPE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT SIII PUMP, CARDIOPULMONARY DTQ COBE CARDIOVASCULAR, INC. SOCKERT SIII *
    2 JOSTRA QUADROX D OXYGENATOR, ECMO DTZ MAQUET, INC. * *
    3 * OXYGENATOR, BLOOD TUBING, ECMO DTZ MEDTRONIC PERFUSION SYSTEMS * 1J28R6

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR