BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 3963335 · Received May 30, 2014

    Report

    Report Number
    9681834-2014-00164
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    TERUMO CORP
    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 COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CONNECTION AT THE 3/8" REDUCER/OUTLET OF THE RESERVOIR LEAKED. THE USER RIGGED THE CONNECTION BY ADDING A PIECE OF SMALLER TUBING TO STOP THE LEAK; THEREFORE, THE PRODUCT WAS NOT CHANGED OUT. NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIM. THE PRODUCT WAS NOT CHANGED OUT. NO SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318094 FX OXY W/HR & ART FILTER BLOOD GAS OXYGENATOR DTZ TERUMO CORP 1CX FX15RE30 130828

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK