BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2180477 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03831
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE VERIFIED DRIED SOLUTION ON AND BELOW THE REGULATOR. THE FSE REPLACED AND ADJUSTED THE 10 PSI AIR REGULATOR, DRAINED THE MIST SEPARATORS ON THE HYDRO AND PRIMED THE SYSTEM. NO FURTHER HYDRO LEAKING WAS REPORTED AS OF (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A LEAK FROM THEIR UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER REPORTED A RECURRING FLUID LEAKING FROM THE 10 PSI AIR REGULATOR. THE LEAK WAS FROM THE HYDRO AREA ONTO THE FLOOR. NO FUMES WERE PRODUCED AND THE CUSTOMER WAS NEITHER HARMED NOR NEEDED MEDICAL TREATMENT. BEC CUSTOMER TECHNICAL SERVICE (CTS) PERSONNEL ADVISED THAT LAB PERSONNEL AVOID CONTACT WITH THE FLUID AND TO NOT USE THE SYSTEM UNTIL THE SYSTEM IS EVALUATED BY BEC. NO EFFECT TO PATIENT OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1