BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM HEART PERCUTANEOUS PTVA PUMP

    MDR report key: 820311 · Received February 8, 2007

    Report

    Report Number
    820311
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    January 26, 2007
    Report Date
    February 8, 2007
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A PINHOLE LEAK WAS FOUND IN THE CENTRIFUGAL PUMP BEFORE TRANSPORTING THE PATIENT TO THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM HEART PERCUTANEOUS PTVA PUMP PUMP, LVAD DSQ CARDIAC ASSIST, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR