BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2012496 · Received March 9, 2011

    Report

    Report Number
    2050012-2011-00684
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND WORKED WITH THE CUSTOMER TO INSPECT THE MAIN VACUUM SYSTEM FOR LOOSE CANISTERS AND FITTINGS. THE LEAK WAS COMING OUT OF 10 PSI REGULATOR. SERVICE VISITED THE SITE ON (B)(4) 2011, AND FOUND THAT WASH SOLUTION CANISTER WAS OVERFLOWING AND THE OVERFLOW WAS COMING OUT OF LOW PRESSURE REGULATOR. NO SYSTEM WASTE WAS INVOLVED IN THE LEAK. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE FLOAT SWITCH AND V2 ON THE HYDRO MANIFOLD, FOLLOWED BY SHUTDOWN AND REBOOT OF THE SYSTEM. THE CANISTER NOW FILLED CORRECTLY AND NO MORE LEAKING WAS OBSERVED. THE VACUUM PUMP RECOVERED PROPERLY DURING OPERATION. THE CUSTOMER WAS RUNNING SAMPLES WITHOUT FURTHER PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THE INSTRUMENT WAS GIVING A PRIMARY VACUUM LOW ERROR. THE CUSTOMER STOPPED AND HOMED THE INSTRUMENT AND THEN NOTICED FLUID ON THE FLOOR. NO INJURY WAS REPORTED 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 CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1