BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2192386 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-04237
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON 07/05/2011 AND REPLACED VALVES V11 AND V5. THE FSE CLEANED CRUSTED WASH SOLUTION ON WASH SOLUTION RESERVOIR JAR. THE FSE NOTED THAT THE CONNECTION ON THE WASTE SUMP JAR WAS MIXED UP, AND CORRECTED THE CONNECTION AND PRIMED THE INSTRUMENT. THE FSE RESOLVED THE ISSUE WITH FLOOD ON ACCUMULATOR JAR. THE FSE RESEATED THE SENSOR ON THE NO FOAM AS IT WAS PRODUCING AN ERROR THAT NO FOAM WAS EMPTY. THE FSE TESTED WASH SOLUTION FOR POTASSIUM AND THE RESULTS WERE WITHIN THE SPECIFICATIONS. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) AND REPORTED MULTIPLE ERRORS RECEIVED ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. WHILE TROUBLESHOOTING WITH BEC CUSTOMER TECHNICAL SUPPORT (CTS), THE CUSTOMER FOUND THE WASH CONCENTRATE RESERVOIR WAS OVERFLOWING AND DRIED WASH SOLUTION WAS CAKED ON CANISTER. THE CUSTOMER DID NOT COME INTO CONTACT WITH FLUID AND IT WAS NOT ON THE FLOOR. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. MEDICAL ATTENTION WAS NOT SOUGHT AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1