BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2030385 · Received March 7, 2011

    Report

    Report Number
    1828100-2011-00527
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 7, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE REPORTED THAT THE ROLLER PUMP FAN FUNCTIONED INTERMITTENTLY AND WAS NOISY. THE FILED SERVICE REPRESENTATIVE REPLACED THE FAN. SINCE THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PATIENT 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