BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2981791 · Received February 27, 2013

    Report

    Report Number
    2050012-2013-00121
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: OBSTRUCTION IN CAP PIERCER DRAIN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT THE CAP PIERCER WASH STATION OF A UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND EYE PROTECTION 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. THE CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO RUN SAMPLES WITH THE CAPS OFF AND ASSISTED THE CUSTOMER WITH DISABLING THE CAP PIERCER UNTIL INSTRUMENT WAS SERVICED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED A GRAY PIECE OF TUBE CAP OBSTRUCTING THE DRAIN. THE FSE CLEANED OUT THE DRAIN AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83831 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1