BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1232736 · Received November 14, 2008

    Report

    Report Number
    1828100-2008-00557
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 14, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING SET UP FOR A CARDIOPULMONARY BYPASS SURGERY, AN ERROR MESSAGE WAS ON THE DISPLAY, WHICH WAS FIXED AFTER INSTALLING A NEW POWER SUPPLY. 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 ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE (PLATFORM) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801764

    Patients

    Seq Age Sex Outcome Treatment
    1