BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 2220859 · Received August 23, 2011

    Report

    Report Number
    2050012-2011-04738
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER EXPERIENCED "DI WATER RESERVOIR NOT FILLING" AND "VACUUM AND AIR PRESSURE LOW" ERRORS ON THE PREVIOUS DAY. BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT ON (B)(6) 2011. THE FSE FOUND FLUID UNDER VALVE BANK ON THE HYDRO AND CLEANED SPILL FROM BELOW VALVES. THE FSE REMOVED AND CHECKED ALL VALVES AND REPLACED TUBING AS NEEDED. LEAK WAS DISCOVERED AROUND THE WASH CONCENTRATE RESERVOIR FITTING. THE FSE REPLACED FITTING AND TEFLON TAPE. THE FSE WASHED ALL CUVETTES AND MONITORED FOR LEAKS, BUT NO LEAK WAS FOUND. THE FSE OBSERVED "17 PSI LOW" ERRORS. THE FSE DIAGNOSED PROBLEM AS A CRACKED WASH CONCENTRATE HOUSING, AND ORDERED A REPLACEMENT WASH CONCENTRATE RESERVOIR. ON (B)(4) 2011, THE FSE REPLACED THE WASH CONCENTRATE RESERVOIR ASSEMBLY AND ADJUSTED THE 17 PSI TO 17.3. NO FURTHER LEAKING OR OTHER PROBLEMS WERE NOTED BY THE FSE FOLLOWING THE REPAIR. AS OF (B)(4) 2011, THE CUSTOMER HAS NOT CONTACTED BEC WITH REQUESTS FOR FURTHER ASSISTANCE FOR THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT A FLUID LEAK WAS OBSERVED UNDERNEATH SYNCHRON LX20 PRO CLINICAL SYSTEM. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1