BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR W/O RESERVOIR

    MDR report key: 2772266 · Received October 2, 2012

    Report

    Report Number
    9681834-2012-00059
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    August 14, 2012
    Report Date
    August 14, 2012
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO REC'D THE ACTUAL DEVICE FOR INVESTIGATION AND VISUAL INSPECTION CONFIRMED THE COMPLAINT. THE LUER ON THE MANIFOLD HAD A CRACK. A REVIEW OF THE DEVICE HISTORY RECORD NOTED NO PRODUCTION RELATED PROBLEMS. IT IS LIKELY THE LUER WAS SUBJECTED TO A SHOCK FORCE. (B)(4). 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 PRIME, THE LUER ON THE MANIFOLD WAS LEAKING. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX FX OXYGENATOR W/O RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA CX*FX15E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK