BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1221486 · Received November 5, 2008

    Report

    Report Number
    1828100-2008-00534
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 5, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING A CARDIOPULMONARY BYPASS PROCEDURE, THE PUMP ALARMED AND DISPLAYED THE "OVERSPEED" MESSAGE. THE DEVICE WAS REPLACED AND THE PROCEDURE PROCEEDED WITHOUT INCIDENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1