BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARMEDA COATED BIOPUMP

    MDR report key: 498761 · Received November 20, 2003

    Report

    Report Number
    2184009-2003-00074
    Event Type
    Malfunction
    Date Received
    November 20, 2003
    Date of Event
    October 21, 2003
    Report Date
    October 23, 2003
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES A BLOOD LEAK OCCURRED FROM THE SIDE OF THE UNIT DURING PUMPING. THE DEVICE WAS CHANGED-OUT DURING THE CASE WITH NO CONSEQUENCE TO THE PATIENT. ALTHOUGH THE PATIENT EXPIRED A FEW DAYS LATER, THE DEATH WAS DUE TO THE PATIENT'S HEALTH STATUS PRIOR TO THE EVENT AND WAS UNRELATED TO THE DEVICE CHANGE-OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARMEDA COATED BIOPUMP EXTRACORPOREAL CENTRIFUGAL BLOOD PUMP KFM MEDTRONIC PERFUSION SYSTEMS CBBP50 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention