BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO

    MDR report key: 2213700 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-04473
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYNCHRON LX20 PRO SYSTEM WAS LEAKING VISCOUS MATERIAL FROM THE HYDROPNEUMATIC AREA OF THE INSTRUMENT. NO PATIENTS WERE EXPOSED TO THE SPILLED FLUID. THERE WAS NO EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES. ADDITIONALLY, NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. THERE WERE NO DEATHS, SERIOUS INJURIES OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. . BECKMAN COULTER INC. FIELD SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND A SPLIT TUBE. THE TUBE WAS REPLACED. THE INSTRUMENT WAS PRIMED AND PERFORMANCE TESTED TO ENSURE THE LEAK HAD BEEN RESOLVED. UPON COMPLETION OF THE NECESSARY REPAIRS, THE INSTRUMENT WAS RETURNED INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1