BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 682203 · Received March 1, 2006

    Report

    Report Number
    1828100-2006-00079
    Event Type
    Malfunction
    Date Received
    March 1, 2006
    Date of Event
    January 19, 2006
    Report Date
    March 1, 2006
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTIVE MAINTENANCE, THE ROLLER PUMP DISPLAYED AN "OVERSPEED" MESSAGE AND STOPPED. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE OT 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death