BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3942645 · Received July 17, 2014

    Report

    Report Number
    3942645
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    April 25, 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

    SUSPECTED PUMP THROMBUS, MULTIORGAN DYSFUNCTION, EVIDENCE OF BLOOD IN THE OSTOMY, AKI ANURIA WORSENING HYPERKALEMIA AND REFRACTORY ACIDOSIS, LACTIC ACIDOSIS. ECHO SHOWED SUSPECTED THROMBUS WITH FLOW ONLY THRU THE AORTA BOTH BY DOPPLER & A-LINE TRACING. PRIMARY COD: MULTISYSTEM ORGAN FAILURE (MSOF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418754 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death