BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1841893 · Received September 20, 2010

    Report

    Report Number
    1828100-2010-01496
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 20, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING NON CLINICAL ACTIVITY, THE USER REPORTED THE CENTRIFUGAL SYSTEM FAILED TO DISPLAY THE FLOW READINGS. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING NON CLINICAL ACTIVITY, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM FLOW SENSOR DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 6382

    Patients

    Seq Age Sex Outcome Treatment
    1