BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 9000

    MDR report key: 1170740 · Received September 15, 2008

    Report

    Report Number
    1828100-2008-00427
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    July 24, 2008
    Report Date
    September 15, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K871131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 THE FIO2 VALUES FLUCTUATED. AN ALTERNATE DEVICE WAS EMPLOYED AND THE PROCEDURE CONCLUDED WITHOUT INCIDENT. 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 PERFUSION SYSTEM 9000 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 164300

    Patients

    Seq Age Sex Outcome Treatment
    1