BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS CONSOLE OPEN HEART MACHINE

    MDR report key: 1960446 · Received December 29, 2010

    Report

    Report Number
    1960446
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 29, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING BY-PASS, AN OPEN-HEART CORONARY ARTERY BYPASS GRAFT(CABG)OPERATION WITH CROSS CLAMPING WAS PERFORMED. I NOTICED A RISE IN VENOUS BLOOD RETURN AND A DROP IN ARTERIAL BLOOD FLOW (CARDIAC OUTPUT) DESPITE RAISING THE REVOLUTIONS PER MINUTE (RPM'S) OF THE 550-BIO-CONSOLE. I IMMEDIATELY ENGAGED A HAND CRANK DEVICE AND RESTORED THE CALCULATED BLOOD FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-MEDICUS CONSOLE OPEN HEART MACHINE EXTRACOPOREAL BLOOD PUMP & SPEED CONTROLLER DWA MEDTRONIC 550 BIO-CONSOLE *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR