BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4977113 · Received August 6, 2015

    Report

    Report Number
    4977113
    Event Type
    Death
    Date Received
    August 6, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 7, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, PATIENT ADMITTED WITH N&V X2 WEEKS. UNCLEAR ETIOLOGY. PRESENTS WITH WEAKNESS, DEHYDRATION AND LOW LVAD FLOWS. NUMEROUS PI EVENTS ON DEVICE INTERROGATION OVER THE LAST WEEK CONSISTENT WITH DECREASED ORAL HYDRATION AND N/V. CONSIDER LVAD HEMOLYSIS. HAS DARK URINE X2 WEEKS. ON (B)(6) 2015, LDH DRAWN, 2364. CARDIAC OUTPUT INADEQUATE, WILL NEED ADDITIONAL SUPPORT. LVAD SPEED 9600 RPM, FLOW INTERMITTENTLY READING 3/L/M POWER 5 PI 1.2, CVP 22, SUSPECT VAD THROMBUS. INR, 6.7. ECHO REVEALED MINIMAL FLOW THROUGH HIS VAD CANULA AND DECREASED LVAD FLOW. PATIENT HAS BECOME UNRESPONSIVE REQUIRING INTUBATION AND PRESSORS IN SETTING OF CARDIAC FAILURE. PATIENT HAS SIGNIFICANT THROMBOSIS OF VAD SYSTEM THAT IS NOT AMENEABLE TO SURGICAL REPAIR. PATIENT HAS DEVELOPED MULTISYSTEM FAILURE. PATIENT WAS MADE DNAR AND TRANSITIONED TO COMFORT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520801 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death