BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARMEDA BIO-PUMP

    MDR report key: 489899 · Received October 15, 2003

    Report

    Report Number
    2184009-2003-00065
    Event Type
    Death
    Date Received
    October 15, 2003
    Date of Event
    July 1, 2003
    Report Date
    September 29, 2003
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT UNIT LEAKED BLOOD FROM THE PUMP HEAD DURING ECMO. PATIENT BLOOD LOSS WAS REPORTED DURING UNIT CHANGE-OUT. THE PATIENT EXPIRED SEVERAL DAYS LATER FROM POST-OPERATIVE SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARMEDA BIO-PUMP EXTROCORPOREAL CENTRIFUGAL PUMP KFM MEDTRONIC PERFUSION SYSTEMS CBBP80 0302000564

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death