BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1881277 · Received October 7, 2010

    Report

    Report Number
    1828100-2010-01725
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 7, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THE AIR SENSOR CABLE WAS BLOWN OUT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED. SINCE THIS EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE CABLE ASSEMBLY JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 149892

    Patients

    Seq Age Sex Outcome Treatment
    1