BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 3880105 · Received April 3, 2014

    Report

    Report Number
    9681834-2014-00096
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    TERUMO CORPORATION
    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 HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, 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. FOR THIS REASON, (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT OUT OF BOX ONE OF THE TUBES ON THE FX SAPLING MANIFOLD BROKE OFF. "NO PATIENT INVOLVEMENT AS THIS OCCURRED OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201649 FX OXY W/HR & ART FILTER BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION 1CX*FX25RW 130826

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK