BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 2122226 · Received June 13, 2011

    Report

    Report Number
    2050012-2011-02300
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 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
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED CRACKED TUBING ON V2. AS OF (B)(6) 2011, NO FURTHER RELATED ISSUES OCCURRED AS SEEN IN THE SERVICE NOTES. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), AND REPORTED THAT THEY ARE HAVING A LEAK FROM THE HYDRO ASSEMBLY IN SYNCHRON LX I 725 CLINICAL SYSTEM. THE CUSTOMER STATED THE LEAK WAS COMING FROM THE RIGHT SIDE OF THE HYDRO AND COULD BE A WASH CONCENTRATE OR WASH SOLUTION. CUSTOMER WAS NOT ABLE TO FURTHER ISOLATE THE SOURCE OF THE LEAK. NO INJURY 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