BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2393614 · Received January 2, 2012

    Report

    Report Number
    2050012-2011-08511
    Event Type
    Malfunction
    Date Received
    January 2, 2012
    Date of Event
    December 4, 2011
    Report Date
    December 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LEAK BENEATH THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (LX 20). CUSTOMER REPORTED THAT THERE WAS A PUDDLE UNDER THE HYDROPNEUMATIC AREA, TOWARD THE REAR, BOTH ON THE HYDROPNEUMATIC DRAWER PAN AND ON THE FLOOR OF THE HYDROPNEUMATIC COMPARTMENT. CUSTOMER REPORTED THAT THE LX 20 WAS GENERATING PRESSURE ERRORS. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE V31 WASTE VALVE WAS NOT CLOSING IN A TIMELY MANNER, CAUSING PRESSURE TO BUILD UP INTO THE SYSTEMS AT THE WRONG TIME WHICH IN TURN CAUSED BUBBLE AND OVERFLOW. THE FSE ALSO FOUND A LEAK IN THE V12 VALVE TUBING. THE FSE REPLACED THE V31 VALVE AND REPLACED THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1