BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO D 903 AVANT 2

    MDR report key: 509826 · Received January 28, 2004

    Report

    Report Number
    509826
    Event Type
    Other
    Date Received
    January 28, 2004
    Date of Event
    December 11, 2003
    Report Date
    January 7, 2004
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DTZ
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING OPEN HEART SURGERY IN 2003. SHORTLY AFTER GOING ON BYPASS, PT'S PO2 WAS NOTED TO DROP. SYSTEM WAS CHECKED, BUT TROUBLE-SHOOTING DID NOT REVEAL A PROBLEM. PT'S PO2 ROSE AFTER A FEW MOMENTS. NO EXPLANATION WAS FOUND. INVESTIGATION CONTINUES, BUT OXYGENATOR FAILURE IS CONSIDERED ONE OF THE POSSIBLE CAUSES, THUS THIS REPORT IS BEING MADE OUT OF AN ABUNDANCE OF CAUTION. THERE HAS BEEN NO DEFINITIVE EXPLANTATION OR CAUSE IDENTIFIED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO D 903 AVANT 2 HOLLOW FIBER OXYGENATOR DTZ COBE CARDIOVASCULAR, INC. D903 AVANT 2 0306190237

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other