BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVA NOVA CP5

    MDR report key: 19174006 · Received April 23, 2024

    Report

    Report Number
    MW5154164
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 19, 2024
    Report Date
    April 20, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CENTRIFUGAL PUMP FAILURE PRIOR TO CARDIOPULMONARY BYBASS. STAFF IMMEDIATELY TOLD THE SURGEON THE ISSUE AND CLAMPED MY LINES TO TROUBLESHOOT THE ISSUE. THE ALARM DISAPPEARED, AND THE PUMP WAS WORKING AGAIN. WE CHANGED OUT THE PUMP AND PUMP HEAD FROM THE DISPOSABLE, TESTED THE NEW PUMP AND RECIRCULATED THE BLOOD FOR A FEW MINUTES AS WELL AS FLASHED THE LINES CONNECTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145680 LIVA NOVA CP5 CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND GMBH 60E02686

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female