BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1970021 · Received January 14, 2011

    Report

    Report Number
    1828100-2011-00074
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 14, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE USER REPORTED THE TOTAL RUN TIME HOURS OF THE PUMP WERE INACCURATE. THE USER FOUND NO HISTORY OR VISUAL SIGNS THAT THE DISPLAY BOARD WAS REPLACED, WHICH WOULD INDICATE THE RUN TIME WAS RESET. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 ROLLER PUMP JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 16400

    Patients

    Seq Age Sex Outcome Treatment
    1