BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFFINITY HOLLOW FIBER OXYGENATOR

    MDR report key: 494933 · Received November 7, 2003

    Report

    Report Number
    2184009-2003-00071
    Event Type
    Death
    Date Received
    November 7, 2003
    Date of Event
    October 7, 2003
    Report Date
    October 8, 2003
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING BYPASS THE OXYGENATOR BROKE, BUT THE HCP DID NOT CHANGE-OUT OR REPLACE THE UNIT AND TERMINATED BYPASS EARLY. PT EXPIRED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY HOLLOW FIBER OXYGENATOR HOLLOW FIBER OXYGENATOR DTZ MEDTRONIC PERFUSION SYSTEMS 511 0306003207

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death