BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY RX05 OXY W/ HR

    MDR report key: 3181688 · Received June 14, 2013

    Report

    Report Number
    9681834-2013-00082
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 28, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K022115
    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 REC'D 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 COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING A BYPASS PROCEDURE FOR ANIMAL RESEARCH (PIG EXTRACORPOREAL MEMBRANE OXYGENATION), THE OXYGENATOR DID NOT OXYGENATE AS EXPECTED. THE ARTERIAL BLOOD GRADUALLY TURNING DARK. NO KNOWN CONSEQUENCE OR IMPACT TO PT. PRODUCT WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271986 BABY RX05 OXY W/ HR BLOOD-GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA N111924

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK