BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC PERFUSION SYSTEM

    MDR report key: 304870 · Received November 2, 2000

    Report

    Report Number
    MW4002853
    Event Type
    Malfunction
    Date Received
    November 2, 2000
    Date of Event
    October 11, 2000
    Report Date
    October 16, 2000
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE OXYGENATOR NOTICED INTRA-OPERATIVELY. PTS ARTERIAL BLOOD WAS DARK. IMMEDIATE INTERVENTION REQUIRED TO CHANGE OXYGENATOR. PT'S BODY TEMPERATURE COOLED TO 27 DEGREES, BYPASS INTERRUPTED. PT PLACED BACK ON BYPASS AND ARTERIAL. BLOOD IMMEDIATELY BECAME RED. PT ALERT, MOVE ALL EXTREMITIES POST-OP. EXTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PERFUSION SYSTEM OXYGENATOR DTZ MEDTRONIC PERFUSION SYSTEMS * 0009001122

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other