BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ECMO OXYGENATOR

    MDR report key: 663153 · Received December 16, 2005

    Report

    Report Number
    663153
    Event Type
    Other
    Date Received
    December 16, 2005
    Date of Event
    December 13, 2005
    Report Date
    December 16, 2005
    Manufacturer
    MEDTRONICS PERFUSION SYSTEMS
    Product Code
    DTZ
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTED SMALL LEAK OF BLOOD AFTER 26 HOURS FROM GAS EXHAUST PORT AFTER HOOK UP FOR PATIENT USE. OXYGENATOR CHANGED IMMEDIATELY WITH DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ECMO OXYGENATOR OXYGENATOR DTZ MEDTRONICS PERFUSION SYSTEMS 0800 0507000855

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA