BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4587775 · Received March 10, 2015

    Report

    Report Number
    1061932-2015-00418
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 12, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 02/13/2015. THE FSE CLEANED THE AREA WHERE THE LEAK HAD POOLED AND FOUND THE VCS (VOLUME CONDUCTIVITY SCATTER) WASTE LINE DISCONNECTED FROM THE DISTRIBUTION VALVE ASSEMBLY. THE DISTRIBUTION VALVE DIRECTS PREPARED SAMPLE FROM THE MIX CHAMBERS TO THE PENDING SAMPLE LINE AND DIRECTS DILUENT RINSE TO THE MIX CHAMBERS AND THEN DIRECTLY TO WASTE. THE FSE ALSO FOUND THAT SOLENOID VALVE VL260 WAS NOT WORKING. VL260 DRAINS THE RETIC STAIN CHAMBER. THE FSE REPLACED THE WASTE LINE TUBING AND VL260 AND THE INSTRUMENT RAN WITHOUT ISSUES. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DILUENT FLUID LEAK OF APPROXIMATELY 10ML FROM A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WHILE PERFORMING MAINTENANCE. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND WAS POOLED IN A RUSTY AREA. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, EYE GLASSES, AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163452 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1