BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3242254 · Received July 15, 2013

    Report

    Report Number
    3242254
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    March 25, 2013
    Report Date
    July 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SEEN IN CLINIC AND HIS HEMOLYSIS LABS WERE ELEVATED. PUMP AND CONTROLLER CHANGED. THROMBUS SUSPECTED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NONE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327719 HEARTMATE II LVAD VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR