BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX

    MDR report key: 243870 · Received October 8, 1999

    Report

    Report Number
    243870
    Event Type
    Death
    Date Received
    October 8, 1999
    Date of Event
    September 23, 1999
    Report Date
    October 8, 1999
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING BYPASS SURGERY THE BLOOD OXYGENATOR FAILED TO ADEQUATELY OXYGENATE THE PT'S BLOOD. THE OXYGENATOR WAS SWAPPED OUT. SURGERY CONTINUED AND THE NEW OXYGENATOR WORKED PROPERLY. PT SUBSEQUENTLY DIED ON 10/3/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX BLOOD OXYGENATOR DTZ TERUMO MEDICAL CORP. SX10 R WK02

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death