BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY FX OXY W/HR & ART FILTER

    MDR report key: 3880079 · Received April 3, 2014

    Report

    Report Number
    9681834-2014-00097
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 17, 2014
    Manufacturer
    TERUMO CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 INFORMATION BECOMES AVAILABLE. FOR THIS REASON, (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS THE FX OXYGENATOR WOULD NOT OXYGENATE APPROPRIATELY. THE PERFUSIONIST HAD A DIFFICULT TIME MAINTAINING PO2 AND VENOUS SATURATION. NO KNOWN IMPACT OR CONSEQUENCES TO PATIENT. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201379 BABY FX OXY W/HR & ART FILTER BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION 1CX*FX05RE 130531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK