BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/O RESERVOIR

    MDR report key: 4177112 · Received October 14, 2014

    Report

    Report Number
    9681834-2014-00272
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    TERUMO CORP, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K130520
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO CORP HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT PRIOR TI CARDIOPULMONARY BYPASS SURGERY, DURING SETUP, THE PURGE LINE CONNECTOR BROKE AFTER TAPPING THE UNIT TO REMOVE AIR. NO PT INVOLVEMENT AS THIS OCCURRED DURING SET UP. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650020 FX OXY W/O RESERVOIR BLOOD GAS OXYGENATOR DTZ TERUMO CORP, ASHITAKA ICX*FX15E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK