BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3246175 · Received July 24, 2013

    Report

    Report Number
    3246175
    Event Type
    Death
    Date Received
    July 24, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 25, 2013
    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

    PATIENT ADMITTED ON (B)(6) 2013 FOR GI BLEEDING. LFT'S. RFT, LACTATE AND HEMOLYSIS LABS ELEVATED. RHC DONE ON (B)(6) 2013 SHOWED LOW CO/CI WITH ELEVATED PA/PWP/CVP. ECHO DONE DEMONSTRATED A DECREASE IN FLOW THROUGH THE LVAD PUMP.

    Description of Event or Problem · 1

    PATIENT ADMITTED ON (B)(6) 2013 FOR GI BLEEDING. LFT'S. RFT, LACTATE AND HEMOLYSIS LABS ELEVATED. RHC DONE ON (B)(6) 2013 SHOWED LOW CO/CI WITH ELEVATED PA/PWP/CVP. ECHO DONE DEMONSTRATED A DECREASE IN FLOW THROUGH THE LVAD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346824 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death