BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTMIA XP

    MDR report key: 2940953 · Received February 2, 2006

    Report

    Report Number
    2940953
    Event Type
    Injury
    Date Received
    February 2, 2006
    Date of Event
    January 26, 2006
    Report Date
    February 1, 2006
    Manufacturer
    COBE CARDIOVASCULAR
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OXYGENATOR RESERVOIR LEAKING PERFUSION BLOOD FROM BOTTOM OF MEMBRANE DURING CARDIO BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTMIA XP DISPOSABLE BLOOD OXYGENATOR DTZ COBE CARDIOVASCULAR XP XPENXX

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening