BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2815660 · Received November 1, 2012

    Report

    Report Number
    2815660
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 18, 2012
    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

    THE PT HAD A RED HEART ALARM. THE PUMP SHUT OFF AND CONTROLLER CHANGED OUT PUMP UNABLE TO TURN BACK ON. THIS IS DUE TO HEMOLYSIS. HMII SHUT OFF. TEE COMPLETED. GRIM OUTCOME GIVEN DNR/DNI

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1