BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX CLINICAL SYSTEM, MODEL LX20 PRO

    MDR report key: 2339894 · Received November 17, 2011

    Report

    Report Number
    2050012-2011-07474
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    October 15, 2011
    Report Date
    October 15, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K014034
    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

    CUSTOMER CALLED TO REPORT THAT THE ELECTROLYTE INJECTION CUP (EIC) ON THE SYNCHRON LX CLINICAL SYSTEM, MODEL LX20 PRO, WAS OVERFLOWING DURING ION SELECTIVE ELECTRODE (ISE) MAINTENANCE. CUSTOMER STATED THAT THE CALCIUM AND CHLORIDE ELECTRODE TIPS WERE REPLACED THAT SAME DAY. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ADVISED CUSTOMER TO CHECK TO DETERMINE WHETHER THE LINE TUBING UNDERNEATH THE FLOW CELL OF THE EIC WAS CRIMPED. CUSTOMER CONFIRMED THAT IT WAS NOT CRIMPED. NEXT, THE CTS INSTRUCTED CUSTOMER TO PUT THE ISE ON SERVICE MAINTENANCE, THEN TO REMOVE THE EIC AND TO FLUSH ALL OF ITS PORTS. CUSTOMER WAS THEN INSTRUCTED TO REPLACE THE EIC, THEN PRIME AND CALIBRATE. THE CTS CALLED CUSTOMER SHORTLY AFTER, AND CUSTOMER CONFIRMED THAT THE TROUBLESHOOTING DESCRIBED ABOVE EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE AS THE EIC WAS PROPERLY DRAINING ONCE AGAIN. CUSTOMER STATED THAT THE ROOT CAUSE WAS LIKELY A PLUG IN ONE OF THE EIC PORTS. CUSTOMER STATED THAT NO PATIENT RESULTS OR SAMPLES WERE AFFECTED, AND THAT NO ONE WAS EXPOSED TO OR HARMED BY THE LEAK/OVERFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX CLINICAL SYSTEM, MODEL LX20 PRO ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX20 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1