BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1063666 · Received June 20, 2008

    Report

    Report Number
    1828100-2008-00322
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 20, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING AN EXHIBITION EVENT, THE FIELD SVC ASSOCIATE REPORTED THE ROLLER PUMP DISPLAYED A "MOTOR ERROR" MESSAGE. THERE WAS NO PT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1