BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBC FLOW PUMP

    MDR report key: 351907 · Received August 11, 2001

    Report

    Report Number
    1645362-2001-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2001
    Date of Event
    August 3, 2001
    Report Date
    August 8, 2001
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORP.
    Product Code
    KFM
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 20 MINUTES INTO A ONE HOUR CABG, THE IBC CONE BEGAN TO SHAKE AND MAKE NOISE. REMOVING THE CONE FROM THE DRIVE TO RECOUPLE THE MAGNETS DID NOT IMPROVE THE PROBLEM OF THE NOISE. FLOW WAS MAINTAINED AT A CARDIAC INDEX OF 2.6 - 2.8 UNTIL THE CONE FAILED. THE A & V LINES WERE CLAMPED, AND THE HEART WAS MANIPULATED BY THE FIELD AND VENTILATION MADE BY ANESTHESIA. A NEW CONE WAS CUT INTO PLACE, PRIMED AND THE PT WAS BACK ON BYPASS IN LESS THAN 2 MINUTES. ALL MANUFACTURERS OF DISPOSABLES OF THE PUMP CONSOLE HAVE BEEN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36713 IBC FLOW PUMP CENTRIFUGAL PUMP KFM INTERNATIONAL BIOPHYSICS CORP. 6000 135101

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention