BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1921690 · Received December 7, 2010

    Report

    Report Number
    1828100-2010-02453
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 7, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER REPORTED THE ROLLER PUMP WAS OUT OF TOLERANCE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, 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. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1