BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARMEDA BIO-PUMP

    MDR report key: 470066 · Received July 2, 2003

    Report

    Report Number
    2184009-2003-00043
    Event Type
    Death
    Date Received
    July 2, 2003
    Date of Event
    May 27, 2003
    Report Date
    June 2, 2003
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE UNIT CRACKED AND LEAKED AFTER 4 HOURS OF ECMO USE AND WAS CHANGED-OUT DURING THE CASE. ALTHOUGH THE PT LATER EXPIRED, THE HEALTH CARE PROFESSIONAL STATED THE DEATH WAS NOT DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARMEDA BIO-PUMP EXTRACORPOREAL CENTRIFUGAL PUMP KFM MEDTRONIC PERFUSION SYSTEMS CBBP80 0109001009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death