BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1953338 · Received January 8, 2011

    Report

    Report Number
    2050012-2011-00012
    Event Type
    Malfunction
    Date Received
    January 8, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) PRIMED THE INSTRUMENT 40 TIMES AND DID NOT SEE ANY SIGN OF LEAKING IN THE HYDRO AREA. THE FSE FOUND CUVETTES FAILED WATER BLANK ERROR AND REPLACED TWO CUVETTES. THE FSE ALSO REPLACED A BENT CUVETTE WASH PROBES. THE FSE PERFORMED PHOTOMETER AND LPIA CUVETTE CENTER TEST, RAN CUVETTES WASH, AND HAD THE CUSTOMER RUN CONTROLS. THE FSE CHECKED THE HYDRO AREA AGAIN AND CONFIRMED NO LEAK FROM THE SYSTEM. THE FSE FOLLOWED-UP WITH THE CUSTOMER ON THE NEXT DAY AND CONFIRMED NO SIGN OF LEAKAGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK ON SYNCHRON LXI 725 CLINICAL SYSTEM. THE CUSTOMER HEARD A NOISE AND NOTICED FLUID WAS SPEWING FROM THE HYDROPNEUMATIC AREA. WHEN THE SYSTEM WAS STOPPED, THE FLUID WAS NOT SPEWING, BUT THE CUSTOMER OBSERVED SIGN OF DRIPPING. THE LEAKAGE MAY HAVE COME FROM THE CUVETTES AND MAY CONTAIN BIO-HAZARDOUS MATERIAL. 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 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1