BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1760959 · Received July 14, 2010

    Report

    Report Number
    1828100-2010-00879
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    May 26, 2010
    Report Date
    July 14, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE HEART LUNG CONSOLE COULD NOT CONNECT TO THE ONLINE BLOOD GAS PARAMETER. THE USER OBSERVED THE ERROR MESSAGE "P02=999" DISPLAYED ON THE CENTRAL CONTROL MONITOR. THE USER REPORTED THE INTERFACE MODULE FAILED TO CONNECT TO THE DEVICE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED AFTER THE CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 INTERFACE MODULE CDI500 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 803479

    Patients

    Seq Age Sex Outcome Treatment
    1