BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX SX25 OXYGENATOR

    MDR report key: 1003212 · Received February 26, 2008

    Report

    Report Number
    1124841-2008-00003
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 28, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS VISUALLY EXAMINED AND LEAK TESTED. THIS EVALUATION CONFIRMED BROKEN HOLLOW FIBERS TO BE THE CAUSE OF THE REPORTED LEAKAGE. ALL UNITS ARE LEAK TESTED DURING PRODUCTION, AND THERE WERE NO INDICATIONS OF ANY PRODUCTION RELATED PROBLEMS IN THE DEVICE HISTORY RECORDS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE WITH SPECIFIC DIRECTIONS TO PRIME THE ENTIRE OXYGENATOR CIRCUIT WHILE THOROUGHLY CHECKING FOR ANY SIGNS OF LEAKAGE PRIOR TO USE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING PRIMING OF THE OXYGENATOR CIRCUIT, THE PERFUSIONIST NOTICED FLUID LEAKING FROM THE BOTTOM OF THE OXYGENATOR. THE UNIT WAS CHANGED OUT PRIOR TO THE START OF THE BYPASS PROCEDURE. THEREFORE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX25 OXYGENATOR OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA HK13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA