BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LXI® 725 CLINICAL SYSTEM

    MDR report key: 2060408 · Received April 16, 2011

    Report

    Report Number
    2050012-2011-01178
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 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
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COULD NOT ISOLATE THE SOURCE OF THE LEAK. A BCI FIELD SERVICE ENGINEER (FSE) FOUND THE LEAK WAS CAUSED BY LOOSE SOLENOID FOR THE RINSE (WATER) ON THE CUVETTE WASH MANIFOLD. THE SOLENOID WAS NOT DEFECTIVE; IT WAS LOOSENED FROM THE MANIFOLD. FSE TIGHTENED DOWN THE SOLENOID, THE INSTRUMENT WAS OPERATIONAL.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INSTRUMENT LEAK COMING FROM THE HYDRO WHICH APPEARED TO BE WASTE AND/OR NO-FOAM. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1