BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 2117437 · Received June 8, 2011

    Report

    Report Number
    2050012-2011-02044
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO STOP SYSTEM FUNCTION AND PLACE PAPER TOWELS ON FLOOR. CTS ASSISTED CUSTOMER POWERING DOWN AND REBOOTING THE SYSTEM POWER. THIS DID NOT PROBLEM NOT RESOLVED. FIELD SERVICE ENGINEER (FSE) FOUND THAT WASH CONCENTRATE WAS BUBBLING AT WASH CONCENTRATE BOTTLE. FSE REPLACED VALVE V-14 AND CLEAN WASH FROM ALL CANISTERS.

    Additional Manufacturer Narrative · 1

    CHANGE FROM: UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. TO: SYNCHRON LX 20 PRO CLINICAL SYSTEMS. CHANGE MODEL NUMBER DXC800 PRO, CATALOG NUMBER A11812. TO: MODEL NUMBER LX20 PRO, CATALOG NUMBER 476100. CHANGE FROM: K042291 TO: K011213.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO WASH CONCENTRATE 2 LEAK. CUSTOMER IS UNABLE TO LOCATE SOURCE OF LEAK. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. LX20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1