BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® SYSTEM

    MDR report key: 2148015 · Received July 2, 2011

    Report

    Report Number
    2050012-2011-02534
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED ON (B)(4) 2011 AND CONFIRMED THAT DURING PRIMING SEQUENCE AN IMPORTANT MESSAGE APPEARED ON CONSOLE STATING "GRAVITY WASTE CANISTER FULL." THE FIELD SERVICE ENGINEER (FSE) PRIMED THE INSTRUMENT AND OBSERVED ACTION OF GRAVITY WASTE CANISTER IN BACK OF HYDRO COMPARTMENT AND CONFIRMED THAT AFTER SEVERAL PRIMES, LIQUID BEGAN TO LEAK OUT OF TOP OF GRAVITY WASTE CANISTER. THE FSE REMOVED THE GRAVITY WASTE CANISTER AND EMPTIED OUT THE CONTENTS. THE FSE ALSO REMOVED A LARGE AMOUNT OF CLEAR THICK FILM THAT HAD SETTLED AT THE BOTTOM OF THE GRAVITY WASTE CANISTER PREVENTING LIQUID WASTE FROM DRAINING OUT OF THE CANISTER. THE FSE CLEANED THE GRAVITY WASTE CANISTER WITH BLEACH, RINSED AND RE-INSTALLED. THE FSE SPRAYED BLEACH INTO BOTH MIXER PADDLE WASH STATIONS TO HELP BREAK UP ANY WASTE IN THE TUBING THAT COULD BE BEGINNING TO FORM FILM. THE FSE PRIMED THE INSTRUMENT AND VISUALLY VERIFIED THE GRAVITY WASTE CANISTER FILLING WITH LIQUID WASTE, AND DRAINING FROM BOTTOM PORT ON GRAVITY WASTE CONTAINER THROUGH WASTE TUBE. NO FURTHER LEAKS WERE OBSERVED IN HYDRO COMPARTMENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A LEAK FROM UNICEL DXC 600 PRO SYNCHRON SYSTEM ONTO THE FLOOR. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT, AND HAS A HAZARD MANAGEMENT PLAN IN PLACE. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED. 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® SYSTEM DISCRETE PHOTOMETRIC CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1