BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2910204 · Received January 11, 2013

    Report

    Report Number
    2910204
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 8, 2012
    Report Date
    January 10, 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 COMPLAINED OF DARKER COLORED U/O. PT ADMITTED AND FOUND TO HAVE PUMP HEMOLYSIS. LDH 3711, CNP 125, PLASMA FREE 94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18353 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1