BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2387954 · Received December 23, 2011

    Report

    Report Number
    2050012-2011-08540
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    November 27, 2011
    Report Date
    November 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT FLUID WAS COLLECTING UNDERNEATH THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WHEN IN HOME POSITION. THE CUSTOMER TECHNICAL SPECIALIST (CTS) IDENTIFIED THE LEAKING FLUID AS EITHER DI H20 (REAGENT CONTAINER RINSE) OR WASH SOLUTION, THEN SCHEDULED A SERVICE VISIT. ON THE FOLLOWING DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE CC SAMPLE PROBE WAS DRIPPING FLUID. THE FSE TROUBLESHOT THE INSTRUMENT BY REMOVING THE WASH LINE FROM THE COLLAR WASH, AND THEN BY PRIMING THE INSTRUMENT. THE FSE THEN SWAPPED THE T-VALVES FROM THE MODULAR CHEMISTRY (MC) SYRINGE TO THE CC SYRINGE. THE DRIPPING CEASED ON THE CC SAMPLE PROBE; HOWEVER, AFTER PRIMING, THE MC SAMPLE PROBE WAS DRIPPING FLUID. THE FSE DETERMINED THAT THE ROOT CAUSE OF THE ISSUE WAS DUE TO A T-VALVE ISSUE. THE FSE ORDERED THE REQUIRED REPLACEMENT PARTS AND RETURNED ON THE FOLLOWING DAY TO REPLACE THE T-VALVE, AFTER WHICH NO FURTHER LEAKING WAS OBSERVED. AFTER TESTING QUALITY CONTROLS, THE FSE VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER STATED THAT NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THAT NO ONE WAS HARMED BY OR EXPOSED TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1