BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 2093941 · Received May 18, 2011

    Report

    Report Number
    2050012-2011-01640
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FOUND THE WASH CONCENTRATE BOTTLE LEAKING AND THEY CHECKED THE WASH CONCENTRATE CANISTER, HYDRO TUBING AND THE STATUS SCREEN. THE CUSTOMER DID NOT SEE ANY ERRORS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED VALVES V5 AND V14. AS OF (B)(4) 2011, NO FURTHER ISSUES OCCURRED AS SEEN IN THE SERVICE HISTORY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), AND REPORTED THAT SYNCHRON LX I 725 CLINICAL SYSTEM WAS LEAKING IN THE HYDRO AREA. THE CUSTOMER CLEANED UP THE SPILL IN FRONT OF THE INSTRUMENT USING PERSONAL PROTECTIVE EQUIPMENT (PPE). NO CHEMICAL EXPOSURE HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1