BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2180516 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03316
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) GENERATED A SERVICE REQUEST. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND FOUND TUBES ON 2 VALVES WERE CRACKED AND REPLACED THE TUBES. FSE FOUND A BROKEN FITTING ON ONE OF THE VALVES AND REPLACED THE VALVE. INSTRUMENT WAS PRIMED 10 TIMES AND CUSTOMER TESTED QC. THE HYDROPNEUMATIC WAS CHECKED FOR LEAKING AND NONE WAS OBSERVED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT YELLOWISH FLUID WAS SLOWLY SEEPING OUT FROM UNDER THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER DID NOT KNOW THE SOURCE OR IDENTITY OF THE LIQUID. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1