BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4547432 · Received February 25, 2015

    Report

    Report Number
    1061932-2015-00307
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON (B)(4) 2015. THE FSE FOUND CLEANER BUILD UP AT FITTING FF252 CAUSED BY A PINHOLE IN TUBING THROUGH FITTING FF260. THE TUBING THROUGH FF260 IS THE WASTE LINE COMING FROM THE DIFF MIX CHAMBER. THE FSE REPLACED THE TUBING AND THE INSTRUMENT RAN WITHOUT LEAKS OR BACKGROUND ISSUES. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEANER FLUID LEAK OF APPROXIMATELY 0.3 ML FROM THE MIX MODULE ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER LATER REPORTED THAT DIFF BACKGROUNDS WERE FAILING, AND THE INSTRUMENT WAS CONSIDERED INOPERABLE UNTIL SERVICE COULD EVALUATE THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT 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
    131576 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1