BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFFINITY NT INTEGRATED CVR OXYGENATOR

    MDR report key: 1686507 · Received April 22, 2010

    Report

    Report Number
    1686507
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    March 29, 2010
    Report Date
    April 22, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TUBING DISCONNECTED FROM THE OXYGENATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY NT INTEGRATED CVR OXYGENATOR OXYGENATOR AND TUBING DTZ MEDTRONIC PERFUSION SYSTEMS * 10737905

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death