BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 2220069 · Received August 9, 2011

    Report

    Report Number
    1124841-2011-00349
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K062381
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVAL, HOWEVER, PHOTOGRAPHIC IMAGES OF THE OXYGENATOR CONFIRMED DAMAGE TO YELLOW LUER CAP ON TOP OF RESERVOIR. A RETENTION SAMPLE WAS ALSO EVALUATED AND NO DAMAGE WAS NOTED ON THE SAMPLE. (B)(4). THE IFU FOR THE DEVICE GIVES THE CUSTOMER INSTRUCTIONS FOR THE PROPER SETUP AND HANDLING OF THE DEVICE. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND F/U.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS, THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SET-UP, THE DEAD END CAP ON THE OXYGENATOR WAS BROKEN. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING SET-UP. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX RX OXYGENATOR BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA NE18

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK