BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX ADULT OXYGENATOR (SX 18 SERIES)

    MDR report key: 51758 · Received September 28, 1996

    Report

    Report Number
    9681834-1996-00010
    Event Type
    Malfunction
    Date Received
    September 28, 1996
    Report Date
    August 28, 1996
    Manufacturer
    TERUMO CORP. ASHITAKA FACTORY
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACTORY PERFORMED IN VITRO GAS TRANSFER PERFORMANCE AND PRESSURE DROP ON THE RETURNED UNIT NO ABNORMALITY WAS FOUND; ALL RESULTS WERE WITHIN FACTORY SPECS. THE ROUTINE MANUFACTURING QUALITY ASSURANCE TEST RESULTS WERE REVIEWED; ALL RESULTS WERE WITHIN SPEC. THE CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    WHEN PT PUT ON BYPASS, ACTIVATION CLOTTING TIME WAS 526, OXYGEN PRESSURE AT 180. WHEN COOLING DOWN TO 27, NORMALLY 250-300 FOR SOMEONE WHO HAS HEMATOCRIT OF 28. PREMEMBRANE PRESSURE WAS 475 AND POST WAS 120. OXYGENATOR WAS RUNNING AT 4-1/2L. IT WAS DECIDED TO CHANGE OUT UNIT BASED ON THE POOR OXYGENATION AND HIGH PRESSURE DROP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX ADULT OXYGENATOR (SX 18 SERIES) HOLLOW FIBER OXYGENATOR DTZ TERUMO CORP. ASHITAKA FACTORY NA 8896A05-77043

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN