BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI® 725 CLINICAL SYSTEM

    MDR report key: 2213566 · Received August 16, 2011

    Report

    Report Number
    2050012-2011-04534
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RECEIVED "WASTE EXIT SUMP SWITCH 11" ERROR ON THE INSTRUMENT. THE WASTE EXIT AND WASTE EXIT B WERE COMPLETELY FULL, AND THE WASTE FLUID SPILLED INTO THE HYDRO DRAWER WHEN THE CUSTOMER LOOSENED THE WASTE CANISTER LIDS. THE CTS DIRECTED THE CUSTOMER TO EMPTY BOTH CANISTERS. THE CUSTOMER TRIED HOMING BUT THE EXIT SUMPS FILLED AGAIN AND THE SAME ERROR MESSAGE WAS ENCOUNTERED. THE CTS EXPLAINED TO THE CUSTOMER THAT THE WASTE FILTERS MAY BE CLOGGED, AND DIRECTED THE CUSTOMER TO REPLACE THE FILTERS. THE CUSTOMER HOMED THE INSTRUMENT AND THEN GOT A "10 PSI LOW ERROR". THE CTS ASSISTED THE CUSTOMER IN STOPPING THE INSTRUMENT AND USING THE MANUAL SWITCH TO FILL THE DI WATER CANISTER 2/3 FULL. INSTRUMENT WAS HOMED AGAIN. THE CUSTOMER STATED THERE WAS FOAM IN THE WASTE CANISTERS, APPROXIMATELY 30% REMAINED IN THE BOTTLE. THE CTS DISCUSSED NO FOAM WITH THE CUSTOMER. THE CUSTOMER WAS TO USE THE INSTRUMENT AND CALL BACK IF FURTHER PROBLEMS. THE CUSTOMER CALLED BACK THE SAME DAY TO REPORT THAT THEY WERE STILL RECEIVING "10 PSI LOW ERROR". THE CTS ASSISTED THE CUSTOMER IN ADJUSTING THE PRESSURE, BUT IT WOULD NOT GO ABOVE 8.9 (ACCEPTABLE RANGE IS 9 TO 11). FITTINGS WERE CHECKED BY THE CUSTOMER BUT NO AIR LEAKS FOUND. THE CTS GENERATED A SERVICE REQUEST. BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT ON (B)(4) 2011. THE FSE VERIFIED 10 PSI PRESSURE ERROR AT 7 PSI. THE FSE VERIFIED REGULATOR OPERATION, AND TRACED AIR LINES FOR LEAKS. HIGH AND LOW COMPRESSORS WERE SWAPPED. THE FSE DETERMINED THAT THE ROOT CAUSE WAS THE LOW PRESSURE COMPRESSOR, AND ORDERED A NEW COMPRESSOR. ON (B)(4) 2011, THE FSE REPLACED THE 10 PSI PUMP, ADJUSTED THE REGULATOR, PRIMED AND VERIFIED PROPER HYDRO OPERATION. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO TROUBLESHOOT AN ERROR MESSAGE RECEIVED ON SYNCHRON LXI 725 CLINICAL SYSTEM, AND HAD WASTE FLUID SPILLED. THE CUSTOMER WAS WEARING PPE AS RECOMMENDED BY BEC CUSTOMER TECHNICAL SUPPORT (CTS). THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED. 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 LXI® 725 CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1