BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 2031891 · Received March 21, 2011

    Report

    Report Number
    1124841-2011-00122
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K062381
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVAL, AND TESTING WAS CARRIED OUT USING A RESERVE SAMPLE. THE GREEN CAP WAS IN PROPER PLACEMENT ON THE GAS OUTLET PORT, WHICH IS LABELED AS GAS OUTLET. CUSTOMER TECHNIQUE CAUSED THE EVENT. (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 MGMT 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, THE GAS LINE WAS PLACED INCORRECTLY ON THE GAS OUTLET OF THE OXYGENATOR. THE PERFUSIONIST CORRECTED THE ISSUE BEFORE GOING ON BYPASS, AND ATTRIBUTED THE ERROR TO THE GREEN CAP ON THE OUTLET PORT OF THE OXYGENATOR, AS COMPETITOR OXYGENATORS PLACE A GREEN CAP ON THE INLET PORT. THERE WAS NO PT INJURY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX RX OXYGENATOR BLOOD-GAS OXYGENATOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK