BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2560130 · Received May 4, 2012

    Report

    Report Number
    1061932-2012-01358
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    2050012-04/05/2012-0006C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIFF MIX CHAMBER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THERE WAS A BROWN LIQUID LEAK IN THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, A LAB COAT, AND GOGGLES AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS, AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. NO PATIENT RESULTS WERE AFFECTED BY THE LEAK, AND THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THE WASTE FITTING UNDER THE DIFF MIX CHAMBER WAS CLOGGED CAUSING THE CHAMBER TO OVERFLOW. THE FSE CONNECTED A SYRINGE TO THE WASTE FITTING AND WAS ABLE TO REMOVE THE MATERIAL THAT WAS CLOGGING THE WASTE FITTING. THE FSE VERIFIED THE INSTRUMENT PERFORMANCE PER ESTABLISHED PROCEDURE, AND THE RESULTS MET THE PUBLISHED PERFORMANCE SPECIFICATIONS. BLOOD, 6C CELL CONTROL, DILUENT, AND DXH CELL LYSE MAY BE PRESENT IN THE DIFF MIX CHAMBER DURING NORMAL OPERATION, AND DXH CLEANER DURING SHUTDOWN. THE CAUSE OF THE LEAK IS A CLOG IN THE DIFF MIX CHAMBER WASTE FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1