BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2226079 · Received August 29, 2011

    Report

    Report Number
    2050012-2011-04809
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    July 31, 2011
    Report Date
    July 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER IN TROUBLESHOOTING THE ISSUE, AND FOUND LINE # 26 WAS DISCONNECTED. THE CTS DIRECTED THE CUSTOMER TO CLEAN AND RECONNECT THE TUBING WHILE USING APPROPRIATE PPE. THE CUSTOMER WAS TO PERFORM CALIBRATION, QC AND PRIME, AND MONITOR. THE CUSTOMER CALLED THE CTS BACK TO REPORT THAT ELECTROLYTES WERE FAILING CALIBRATION, ALTHOUGH NO LEAKING OR OVERFLOWING WAS OBSERVED. THE CUSTOMER PRIMED THE ISE (ION SELECTIVE ELECTRODE) AND OBSERVED SOME SMALL BUBBLES IN THE RATIO PUMP BUT NOT TUBING. THE CTS DIRECTED THE CUSTOMER TO RECALIBRATE WITH SERUM AND THEN WITH AQUA CAL. THE CTS INSTRUCTED THE CUSTOMER TO DO THE TWICE WEEKLY FLOW CELL CLEANING PROCEDURE IF CALIBRATION FAILED. THE CTS FOLLOWED UP WITH THE CUSTOMER, AND FOUND THE CALIBRATION WAS STILL FAILING FOR ELECTROLYTES. THE CTS HAD THE CUSTOMER CHECK THE FLOW CELL AND EIC (ELECTROLYTE INJECTION CUP) FOR OBSTRUCTIONS, BUT NONE WAS NOTED. THE CUSTOMER PERFORMED SUCCESSFUL CALIBRATION AND QC. THE CUSTOMER WAS TO MONITOR AND CALL BACK IF PROBLEMS CONTINUED. THE CUSTOMER CALLED BACK AND REQUESTED SERVICE ON THE INSTRUMENT. ON (B)(6) 2011, BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT. THE FSE NOTED THAT THE ISE WOULD NOT CALIBRATE NA (SODIUM), K (POTASSIUM), CL (CHLORIDE), AND THAT CO2 (CARBON DIOXIDE) ALKALINE BUFFER WAS EMPTY DUE TO TUBE #29 DISCONNECTED FROM VALVE BLOCK. THE FSE INSTALLED A NEW CARBON BRIDGE AND CLEANED FLOW CELL. THE FSE PERFORMED ISE CALIBRATION INTEGRITY AND PRECISION ASSESSMENT. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A FLUID LEAK ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER WAS ALSO EXPERIENCING DIFFICULTIES IN CALIBRATING ELECTROLYTES. 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 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1