BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 638879 · Received June 14, 2005

    Report

    Report Number
    2916284-2005-00001
    Event Type
    Other
    Date Received
    June 14, 2005
    Date of Event
    May 8, 2005
    Report Date
    May 19, 2005
    Manufacturer
    WORLD HEART, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (I.E., PERFUSION OPERATOR) REPORTED THAT THE NOVACOR LEFT VENTRICULAR ASSIST SYSTEM (LVAS) STOPPED OPERATING. THE MANUFACTURER'S SENIOR CLINICAL SPECIALIST INSTRUCTED THE HEALTH CARE FACILITY STAFF (BY TELEPHONE) TO RECONNECT THE PUMP/DRIVE UNIT DRIVELINE CABLE, MAKING SURE THAT THE CABLE SNAPPED INTO PLACE. UPON RECONNECTING THE DRIVELINE, THE NOVACOR LVAS IMMEDIATELY RESUMED OPERATION. THE PATIENT RECOVERED FROM THE EVENT WITH NO FURTHER INCIDENT. THE DEVICE REMAINS IN SERVICE. A SUBSEQUENT TELEPHONE CALL TO THE MANUFACTURER FROM THE HEALTH CARE FACILITY PERFUSION OPERATOR REPORTED THAT HE WAS CERTAIN THE LVAS STOPPED OPERATING BECAUSE THE PUMP/DRIVE UNIT DRIVELINE BECAME DISCONNECTED FROM THE CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR BYPASS (ASSIST) DEVICE DSQ WORLD HEART, INC. N100PC CONTROLLER *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other