BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2080899 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01422
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO CHECK FOR LOOSE TUBING AND/OR FITTINGS; NONE WERE FOUND. ON (B)(4) 2011 BCI FIELD SERVICE ENGINEER (FSE) PULLED OUT THE HYDRO DRAWER AND PRIMED THE INSTRUMENT 8 TIMES. NO SIGNS OF A LEAK WERE NOTED. THE CUSTOMER CONTINUED TO RUN THE MACHINE WHILE FSE OBSERVED AND NO LEAKS WERE DETECTED. FSE CHECK THE NO FOAM VALVES AND ENSURED ALL WASTE CONTAINERS WERE FILLING AND DRAINING PROPERLY. FSE COULD NOT REPRODUCE THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A HYDRO PNEUMATIC UNIT LEAK ONTO THE DRIP TRAY. PER CUSTOMER, THE LEAK HAS NOT POSED A HAZARDOUS CONDITION TO ANY EMPLOYEES IN THE LABORATORY NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1