BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 3023130 · Received March 27, 2013

    Report

    Report Number
    2050012-2013-00196
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM SHOWED ERROR MESSAGES OF "REACTION WHEEL MOTION ERRORS", "REACTION WHEEL TEMPERATURE ERRORS" AND "CUVETTE NOT DRY BEFORE FIRST REAGENT DISPENSE". UPON TROUBLESHOOTING WITH BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT, THE CUSTOMER OBSERVED THE WASH VACUUM PROBE ON THE CUVETTE WASH STATION WAS LEAKING FLUID. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING A LAB COAT, EYE PROTECTION, AND GLOVES WHEN TROUBLESHOOTING. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. MEDICAL ATTENTION WAS NOT SOUGHT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. BEC FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND INSPECTED THE SYSTEM. THE FSE FOUND THE WASH VACUUM PROBES WERE NOT VACUUMING WASTE DUE TO AN OBSTRUCTED VALVE. THE SEALS ON THE VALVE ALSO LOOKED WORN. THE FSE REPLACED THE VALVE AND VERIFIED THE CUVETTE WASH MANIFOLD OPERATION. THE FSE CONFIRMED THE FAILURE MODE TO BE AN OBSTRUCTED 3 WAY SOLENOID VALVE USED ON THE CUVETTE WASH MANIFOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126064 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1