BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3051337 · Received April 10, 2013

    Report

    Report Number
    3051337
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    November 2, 2012
    Report Date
    April 4, 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

    HEMOLYSIS ON ADMISSION. PUMP THROMBUS SUSPECTED. ON (B)(6) 2012, POWER 10.7-13.1W. PUMP STOPPED AND UNABLE TO RESTART. DEVICE TURNED OFF. TO OR (B)(6) 2012, FOR DEVICE EXCHANGE. THROMBUS EXTENDED FROM VAD TO PROXIMAL PORTION OF OUTFLOW GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149624 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1