BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCE PERFUSION SYSTEM 1

    MDR report key: 1920927 · Received November 8, 2010

    Report

    Report Number
    1828100-2010-02024
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    September 21, 2010
    Report Date
    November 8, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING FIELD SERVICE INSTALLATION OF THE DEVICE. THE SERVICE ENGINEER REPORTED GREASE WAS LEAKING FROM THE ROLLER PUMP BEARING. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCE PERFUSION SYSTEM 1 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 801040

    Patients

    Seq Age Sex Outcome Treatment
    1