BEUDAMED
    FDA Adverse Event Death Summary report: N

    BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

    MDR report key: 420739 · Received October 4, 2002

    Report

    Report Number
    1220648-2002-00001
    Event Type
    Death
    Date Received
    October 4, 2002
    Date of Event
    September 14, 2002
    Report Date
    October 2, 2002
    Manufacturer
    ABIOMED, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RE-EVALUATION OF THE CANNULA POSITION AND SUTURES DUE TO BLEEDING PROBLEMS, THE LEFT SIDE FLOWS OF A BIVAD DROPPED FROM 4.9 L/M TO LESS THAN 1.0 L/M. THE EVENT OCCURRED WHEN THE PATIENT WAS MOVED FROM THE ICU BED TO THE O.R. TABLE. LEFT SIDE FLOWS RANGED FROM 0 L/M TO 1.2 L/M. "LOW PRESSURE-LOW FLOW" AND "HIGH PRESSURE-LOW FLOW" ALARMS WERE INDICATED. THE ATRIAL AND VENTRICULAR BLADDERS OF THE BLOOD PUMP REMAINED NEARLY FULL. RIGHT SIDE FLOWS REMAINED STABLE. AFTER APPROXIMATELY 30 MINUTES OF EXAMINATION LOOKING FOR POSSIBLE KINKS WHICH WERE STATED NOT TO BE FOUND IN THE CANNULA, THE MANUAL FOOT PUMP WAS USED WITH NO IMPROVEMENT. THE CONSOLE WAS TURNED OFF THEN BACK ON WITH NO IMPROVEMENT. THE CONSOLE WAS TURNED OFF THEN BACK ON WITH NO IMPROVEMENT. DR. OFFICIALLY CALLED EXPIRATION OF PATIENT AT 11:30 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM CARDIAC ASSIST DEVICE DSQ ABIOMED, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death