BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3942599 · Received July 17, 2014

    Report

    Report Number
    3942599
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    April 20, 2014
    Report Date
    July 14, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PT WAS NOTED TO BE ANEMIC WITH LOW PI NOT RESPONSIVE ON FLUID. HE WAS HAVING LOW FLOW ALARMS WITH LOW PI, IT WAS PRESUMED PUMP THROMBOSIS. ON (B)(6) 2014, THE PUMP STOPPED AND AT THAT POINT, THE DRIVELINE WAS DISCONNECTED. ON (B)(6) 2014, HE DIED. PRIMARY COD: DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418668 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death