BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CV BLOOD PUMP ROLLER

    MDR report key: 1051929 · Received May 12, 2008

    Report

    Report Number
    1051929
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    May 20, 2007
    Report Date
    May 7, 2008
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ECMO CASE, THE CV BYPASS ROLLER PUMP STOPPED AND DISPLAYED ERROR CODE 000004. THE ROLLER PUMP WAS STOPPED FOR ABOUT 30 SECONDS. THE ROLLER PUMP WAS THEN RESTARTED AND ECMO WAS CONTINUED. AFTER ABOUT ONE HOUR, THE ROLLER PUMP STOPPED AGAIN AND DISPLAYED ERROR CODE 000004 AGAIN. IT WAS RESTARTED AND REPLACED WITH ANOTHER ROLLER PUMP. THE PUMP VENDOR WILL PERFORM THE REPAIR OF THIS PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CV BLOOD PUMP ROLLER PUMP, BYPASS DWB COBE CARDIOVASCULAR, INC. 10-60-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA