BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1181048 · Received September 29, 2008

    Report

    Report Number
    1828100-2008-00454
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 29, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE GAS DELIVERY SYSTEM UNEXPECTEDLY CHANGED FROM AIR TO 95-5 AUTOMATICALLY. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE REPORTED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE (GAS MODULE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1