BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2182578 · Received July 28, 2011

    Report

    Report Number
    1061932-2011-01055
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT BUT THE AFFECTED PART WAS RETURNED FOR INVESTIGATION. THE ROOT CAUSE WAS FAULTY ROUTING OF THE WIRING FROM THE TOROID COIL INDUCTOR CAUSING IT TO RUB ON THE ELBOW FITTING WITHIN THE COMPRESSOR PUMP. THE WIRES IN QUESTION CONTAIN 2 X 12 GAUGE SOLID WIRES SO IT DOES NOT MOVE FROM WHERE IT IS POSITIONED. HOWEVER, IN THIS CASE IT WAS NOT ROUTED AWAY FROM THE CONNECTION AND IT BURNT WHEN THE COMPRESSOR VIBRATED AND THE ELBOW FITTING CAME IN CONTACT WITH IT. IT HAD RUBBED THROUGH THE COILED WRAPPER AND THEN THROUGH THE WIRING INSULATION. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. (BEC) PERSONNEL REPORTED THAT THEY FOUND THE WIRING FROM THE TOROID COIL INDUCTOR WITHIN THE PNEUMATIC SUPPLY MODULE ON UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM HAD BURNT OUT. IT WAS FOUND WHILE THEY WERE REPLACING THE COMPRESSOR AT A TRAINING SITE. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT AND NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO EXPOSURE TO ANY SPARKS, FLAMES OR SMOKE. USE OF FIRE EXTINGUISHERS OR SUMMONING OF THE FIRE DEPARTMENT WAS NOT REQUIRED. THERE IS AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE AT THE BEC FACILITY.

    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