BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE

    MDR report key: 1111763 · Received August 11, 2008

    Report

    Report Number
    MW5007970
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 11, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT EN ROUTE TO HOSPITAL VIA AMBULANCE DUE TO UNUSUAL "SWISHING" SOUNDS FROM PUMP, BUT HEARTMATE XVE DEVICE FAILED IN TRANSIT. PT DESCRIBED PUMP STOPPED AND CONTROLLER ALARMED WITH RED HEART. CHANGED CONTROLLER BUT PUMP STOPPED AGAIN ABOUT 5 MINUTES AFTER REPLACEMENT. PT SWITCHED TO THE HAND-PUMP. AMBULANCE EXITED HIGHWAY TO NEARBY HOSPITAL FOR MEDVAC FLIGHT TO IMPLANTING HOSPITAL. THE PT HAD V-TACH RATE APPROX 170 - AND PROGRESSING PULMONARY EDEMA WHILE ON HAND PUMP UPON ARRIVAL TO ER. THE PT WAS IMMEDIATELY SWITCHED TO THE -IP- PNEUMATIC DRIVE CONSOLE IN THE ER. PT CONDITION IMPROVED WITH IP CONSOLE. TESTING OF BOTH CONTROLLERS ON MOCK LOOP REVEALED BOTH CONTROLLERS ARE FULLY FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE NONE DSQ THORATEC CORP. HEARTMATE XVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O