BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 2030064 · Received March 25, 2011

    Report

    Report Number
    2050012-2011-00850
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED ON (B)(4) 2011, AND THE FIELD SERVICE ENGINEER (FSE) FOUND THAT VALVES 12 AND 14 HAD QUITE A BIT OF DRIED WASH CONCENTRATE AROUND TUBING OF VALVES. THE FSE CLEANED VALVES AND SAW A HOLE IN VALVE 14 TUBING. THE FSE REPLACED TUBING, AND HYDRO VALVES 12 AND 14. THE FSE CLEANED UNDER ALL VALVES, BOTTOM OF INSTRUMENT AND FLOOR AND VERIFIED CONCENTRATION OF WASH SOLUTION-K LEVEL OF 4.45 WHICH IS ACCEPTABLE. WASH SOLUTION IS LONGER LEAKING FROM THE HYDRO. THE FSE DETERMINED THAT LEAKING FLUID IS WASH SOLUTION

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A CONTINUOUS NO FOAM LEAK ON SYNCHRON LX I 725 CLINICAL SYSTEM. THE CUSTOMER STATED THE LEAK WAS UNDER THE INSTRUMENT AND IN THE HYDRO DRAWER BUT COULD NOT SEE THE SOURCE. THE CUSTOMER STATED THEY WERE KEEPING TOWELS UNDER THE INSTRUMENT TO KEEP THE LEAK FROM SPREADING AND THEY WERE WEARING PPE WHEN CLEANING UP THE SPILL. THE CUSTOMER STATED THAT THEY HAVE THE MSDS FOR THE NO FOAM AND NO ONE HAD BEEN EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1