BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEMHEART

    MDR report key: 692105 · Received March 28, 2006

    Report

    Report Number
    692105
    Event Type
    Death
    Date Received
    March 28, 2006
    Date of Event
    March 22, 2006
    Report Date
    March 28, 2006
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S ALARM ON TANDEM HEART MACHINE ALARMED, "LOW FLOW", FEMORAL LINE NOTED TO BE DISLODGED, POOL OF BLOOD ON BED/ FLOOR AND PATIENT EXSANGUINATED. CPR INITIATED WITHOUT SUCCESS - PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART LVAD DSQ CARDIAC ASSIST, INC. * *
    2 BIO-MEDICUS CANNULA , FEMORAL ARTERIAL DWF MEDTRONIC , INC. 96570-017 2002020660

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death