BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX25 OXYGENATOR WEST

    MDR report key: 9048726 · Received September 13, 2019

    Report

    Report Number
    1124841-2019-00256
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 22, 2019
    Report Date
    October 2, 2019
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450110
    PMA / PMN Number
    K153213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IDENTIFICATION OF EVALUATION CODES 10, 3331, 3259, 12. THE AFFECTED SAMPLE WAS RETURNED AND INSPECTED UPON RECEIPT. THE L SHAPED CONNECTOR WAS ABLE TO BE READILY REMOVED. THE PROVIDED VIDEO WAS REVIEWED SHOWING THAT THE CONNECTOR WAS NOT ABLE TO BE ONE-HANDEDLY REMOVED. IT IS POSSIBLE THAT IF THE CONNECTOR WAS PRESSED TOGETHER AND SCREWED TOGETHER EXTRA TIGHT, THEN IT MAY BE DIFFICULT TO REMOVE. A GENERAL TRAINING HAS BEEN CONDUCTED TO TAKE CARE WHEN ASSEMBLING LUER CONNECTIONS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARTERIAL SIDE OF MANIFOLD LINE COLLAR IS ROTATING BUT LINE WILL NOT PULL OFF MANIFOLD. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PRODUCT WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820718 CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*RX25RW XC18 00699753450110

    Patients

    Seq Age Sex Outcome Treatment
    1