BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3011821 · Received March 19, 2013

    Report

    Report Number
    2050012-2013-00162
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PLUG FITTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE MODULAR CHEMISTRY (MC) SIDE OF A UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER INDICATED THAT THE IDENTITY AND VOLUME OF THE FLUID ARE UNKNOWN. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND FLUID HAD LEAKED ONTO THE FLOOR. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AND NO EXPOSURE OR INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE PLUG FITTING FOR THE DEIONIZED (DI) WATER PORTION OF THE MC MANIFOLD WAS BROKEN, CAUSING THE LEAK. THE FSE DETERMINED THAT THE FLUID WHICH LEAKED WAS DI WATER AND PROCEEDED TO CLEAN THE SPILL. THE FSE REPLACED THE PLUG FITTING AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114303 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1