BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3121266 · Received May 20, 2013

    Report

    Report Number
    2050012-2013-00318
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED CRACKED CUVETTES, LOOSE WASH TOWER AND DEFECTIVE VALVE V4 ON THE CUVETTE WASH MANIFOLD WHICH WAS NOT TAKING OUT ALL THE FLUID FROM THE CUVETTES. THE FSE REPLACED SEVERAL CRACKED CUVETTES AND VALVE V4 TO RESOLVE THE ISSUE. THE FSE STATED THAT REPLACEMENT OF VALVE V4 RESOLVED THE LEAK. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO VALVE V4. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED LEAK UNDER THE REACTION WHEEL OF THE UNICEL DXC 800 SYNCHRON SYSTEM AND OBTAINED "10 OR MORE CUVETTES FAILING WATER BLANK" ERROR MESSAGES DURING THE EVENT. THE CUSTOMER REMOVED THE REACTION WHEEL TO TROUBLESHOOT THE ERROR MESSAGE AND CLEAN THE CUVETTES AND FOUND FLUID UNDER THE REACTION WHEEL AND ON THE OUTSIDE OF THE CUVETTES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT AND EYE PROTECTION AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222297 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1