BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2194049 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04261
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION, BEC FIELD SERVICE ENGINEER (FSE) FOUND THE LEAK WAS COMING FROM THE PUMP BOX. THE VACUUM EXPANSION CHAMBER DRAIN WAS NOT SEATED PROPERLY IN THE TRAY CAUSING THE FLUID TO DRAIN DIRECTLY ONTO THE FLOOR. THE FSE PROPERLY SEATED THE DRAIN LINE INTO THE TRAY. BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) AND REPORTED A FLUID LEAK ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER COULD NOT TELL THE SOURCE OF THE LEAK. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS EXPOSURE CONTROL PLAN. MEDICAL ATTENTION WAS NOT SOUGHT, AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1