BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRASSIST

    MDR report key: 1250418 · Received November 24, 2008

    Report

    Report Number
    MW5009090
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 21, 2008
    Report Date
    November 24, 2008
    Manufacturer
    VENTRACOR
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED AN ALARM FROM CONTROLLER WITH BLANK SCREEN. CONTROLLER CHANGED. PRIMARY LEAD EXTENSION WAS ALSO CHANGED. PUMP ALARMED AGAIN WITH MESSAGE OF PUMP STARTING. CONTROLLER CHANGED AGAIN. ALARM MESSAGE WITH NEW CONTROLLER SAYS BACK UP CONTROLLER ACTIVE. COORDINATOR CHANGED OUT EXTRACORPEAL AND THEN PUMP WAS NOT PUMPING PER AUSCULTATION WITH STETHOSCOPE, AND PATIENT ARRESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRASSIST LEFT VENTRICULAR DEVICE DSQ VENTRACOR 314185

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening