BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3217647 · Received July 10, 2013

    Report

    Report Number
    3217647
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 8, 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

    ON TETHER CABLE WITH PM POWER - LOW FLOWS - PUMP STOPPED TWICE. TRANSFERRED TO BATTERY AND ALARM STOPPED. ATTEMPTED TO TRANSFER PT TO DATA PORT ON TETHER CABLE FOR WAVEFORMS AND PUMP NOTED RED HRT ALARMS. CHANGED TO NON-GROUNDED TETHER CABLE-NO ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317765 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1