BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1834582 · Received September 9, 2010

    Report

    Report Number
    1828100-2010-01502
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 9, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED, THE OCCLUDER HEAD WOULD NOT REMAIN IN POSITION AND WAS UNABLE TO BE TIGHTENED. NO OTHER DETAILS REGARDING THE NATURE OF THE 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 OCCLUDER MODULE JOR TERUMO CARDIOVASCULAR SYSTEMS CORP 806455

    Patients

    Seq Age Sex Outcome Treatment
    1