BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/O RESERVOIR

    MDR report key: 3813236 · Received March 27, 2014

    Report

    Report Number
    9681834-2014-00087
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS (THE USER) FELT THE OXYGENATOR FAILED TO PROVIDE ADEQUATE GAS TRANSFER PERFORMANCE. THE PO2 WAS APPROXIMATELY 250 MMHG, AND THE VENOUS SATURATIONS AND MIXED VENOUS VALUES WERE GOOD THROUGHOUT THE CASE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179629 FX OXY W/O RESERVOIR BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION ASHITAKA 1CX*FX15W 130904

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK