BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1082620 · Received July 23, 2008

    Report

    Report Number
    1828100-2008-00354
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 23, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PUMP SYSTEM DID NOT RESPOND PROPERLY TO SAFETY SENSOR SIGNALS. WHEN PUMP STOP SIGNALS WERE SENT FROM THE SAFETY SENSORS, THE PUMP DID NOT STOP. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1