BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2211111 · Received August 5, 2011

    Report

    Report Number
    1828100-2011-02354
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT SOME OF THE ELECTRONIC COMPONENTS INSIDE THE MONITOR WERE ON FIRE AND SMOKED CAME OUT OF THE UNIT. THE MONITOR LOST ITS NORMAL APPEARANCE AND WAS NOT ABLE TO BE USED FOR THE REMAINDER OF THE CASE. THE PUMPS WERE CONTROLLED WITH LOCAL KNOBS. THERE WAS A DELAY OF 15 MINUTES, BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 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 CENTRAL CONTROL MONITOR DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1