BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIDECO AVANT 2 OXYGENATOR

    MDR report key: 509974 · Received February 5, 2004

    Report

    Report Number
    509974
    Event Type
    Death
    Date Received
    February 5, 2004
    Date of Event
    December 11, 2003
    Report Date
    January 8, 2004
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DTZ
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING CARDIO PULMONARY BYPASS (CPB) IN 2003. TEN MINUTES INTO THE CPB PT'S PO2 DECREASED. SYSTEM WAS CHECKED, BUT TROUBLESHOOTING DID NOT REVEAL A PROBLEM. PT'S PO2 INCREASED AFTER FEW MINUTES. NO EXPLANATION WAS FOUND. PT REQUIRED SUPPORT TO WEAN FROM CPB. PT DIED IN ICU. INVESTIGATION CONTINUES, OXYGENATOR FAILURE IS CONSIDERED ONE OF THE POSSIBLE CAUSES. THERE HAS NOT BEEN A DEFINITIVE EXPLANTATION ON CAUSE. REFERENCE 1718850-2004-1 AND 450638-2003-10.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O