BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1063663 · Received June 20, 2008

    Report

    Report Number
    1828100-2008-00315
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 20, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR CARDIOPULMONARY BYPASS, THE HEART LUNG CONSOLE GAS FLOW MODULE DID NOT CALIBRATE SUCCESSFULLY. MANUAL CONTROL OF BOTH GAS FLOW AND FIO2 REMAINED AVAILABLE. THERE WERE NO 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. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1