BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 3813238 · Received March 27, 2014

    Report

    Report Number
    9681834-2014-00088
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 7, 2014
    Manufacturer
    TERUMO CORPORATION ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K130520
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT OUT OF BOX, THE RECIRCULATION LINE SEPARATED FROM THE ARTERIAL OUTLET, AND THERE WAS A CRACK NOTED ON THE ARTERIAL OUTLET. NO PATIENT INVOLVEMENT AS THIS OCCURRED OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179933 FX OXY W/HR & ART FILTER BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION ASHITAKA 1CX*FX25RE 130627

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK