BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 4023967 · Received August 14, 2014

    Report

    Report Number
    9681834-2014-00232
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 28, 2014
    Manufacturer
    TERUMO CORP ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    130520
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT DURING CARDIOPULMONARY BYPASS THE RESERVOIR OUTLET (3/8" TO 1/4" CONNECTOR - RESERVOIR OUTLET TO THE OXYGENATOR INLET) HAD A VERY SLOW LEAK. THE CUSTOMER TIGHTENED THE CONNECTION, YET THE SLOW LEAK CONTINUED AS A SMALL DRIP. ALTHOUGH THE PT AGE IS UNK, THE EVENT OCCURRED AT A CHILDREN'S HOSP; THEREFORE, THE CASE IS ASSUMED TO BE PEDIATRIC. TERUMO CONSIDERS ANY BLOOD LOSS IN A PEDIATRIC CASE AS A SERIOUS INJURY. A 3-10 CC BLOOD LOSS. PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486014 FX OXY W/HR & ART FILTER BLOOD GAS OXYGENATOR DTZ TERUMO CORP ASHITAKA 1CX FX15RW30 131126

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other