BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE HVAD

    MDR report key: 3920223 · Received July 8, 2014

    Report

    Report Number
    3920223
    Event Type
    Death
    Date Received
    July 8, 2014
    Date of Event
    April 3, 2014
    Report Date
    June 26, 2014
    Manufacturer
    HEARTWARE, INC.
    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

    PT W/ HVAD DT ON HOME HOSPICE WHO CAME IN WITH LVAD ALARMS. PATIENT ON HOSPICE DUE TO INABILITY TO TOLERATE ANTICOAGULATION. PALLIATIVE CARE CONSULTED AFTER DISCUSSION WITH PT, PATIENT WAS DNR/DNI AND COMFORT CARE. LVAD STOPPED WORKING 2 DAYS LATER. PRIMARY COD: WITHDRAWAL OF SUPPORT, SPECIFY. PRIMARY COD SPECIFY: LOW FLOWS ON LVAD WITHOUT ANTICOAGULATION (ON HOSPICE) AND SUSPICION FOR THROMBUS. LVAD STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397583 HEARTWARE HVAD LVAD DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death