BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1820077 · Received August 24, 2010

    Report

    Report Number
    1828100-2010-01173
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 24, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE, THE SERVICE TECHNICIAN REPORTED THE ROTATION NUMBER INDICATOR WAS DIFFERENT FROM THE OBSERVED FLOW ON THE CENTRIFUGAL CONTROL MODULE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL CONTROL MODULE DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 6379

    Patients

    Seq Age Sex Outcome Treatment
    1