BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1191967 · Received October 1, 2008

    Report

    Report Number
    1828100-2008-00461
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 1, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE ELECTRONIC GAS DELIVERY MODULE UNEXPECTEDLY INDICATED THAT RE-CALIBRATION WAS REQUIRED. AN ALTERNATE DEVICE WAS EMPLOYED. THE PROCEDURE CONCLUDED WITHOUT INCIDENT. MANUAL ADJUSTMENTS OF GAS FLOW RATE AND FIO2 REMAINED AVAILABLE. THERE WAS NO ADVERSE CONSEQUENCE 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