BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 3960349 · Received June 23, 2014

    Report

    Report Number
    9681834-2014-00189
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, 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 CORPORATION THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE PRESSURE LINE FROM THE SAMPLING MANIFOLD TO THE BLOOD OUTLET DISCONNECTED AND WAS CRACKED. NO PT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS NOT USED. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366079 FX OXY W/HR & ART FILTER BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA 1CX *FX25RE 130829

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK