BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM ONE

    MDR report key: 1182695 · Received September 25, 2008

    Report

    Report Number
    1828100-2008-00446
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 25, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR CARDIOPULMONARY BYPASS SURGERY, THE FLOW RATE MODULE DISPLAYED A "BACKFLOW" ERROR MESSAGE ONCE THE DEVICE WAS POWERED ON. AN ALTERNATE DEVICE WAS EMPLOYED. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM ONE HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1