BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1981706 · Received January 29, 2011

    Report

    Report Number
    1981706
    Event Type
    Malfunction
    Date Received
    January 29, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 29, 2011
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEFT VENTRICULAR ASSIST DEVICE (LVAD) WATTS HAD BEEN RISING AND PATIENT WAS BEING FOLLOWED FOR POSSIBLE CLOT FORMATION IN THE DEVICE. POWER REQUIREMENT OF LVAD ROSE DRAMATICALLY TO 15 WATTS. RED HEART (NO FLOW) ALARMS WENT OFF SEVERAL TIMES. NURSE CHANGED CONTROLLER. RED HEART ALARMS AGAIN INDICATED NO FLOW CONDITION THROUGH LVAD. PATIENT TAKEN TO OR EMERGENTLY IN THE MIDDLE OF THE NIGHT. LVAD AND OUTFLOW GRAFT CHANGED OUT FOR NEW. PICTURES WERE TAKEN TO DOCUMENT QUANTITY OF CLOT THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD VENTRICULAR ASSIST DEVICE DSQ THORATEC 103695 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR