BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4596435 · Received March 12, 2015

    Report

    Report Number
    1061932-2015-00441
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Date of Event
    February 16, 2015
    Report Date
    February 16, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 02/16/2015. THE FSE CONFIRMED THAT THE QUICK DISCONNECT QD421 TUBING ALSO CALLED THE PROBE WASH COLLAR TUBING, BECAME DISCONNECTED FROM THE MANIFOLD; THE TUBING WAS RESEATED AND THE LEAK WAS RESOLVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLOOD AND DILUENT FLUID LEAK OF APPROXIMATELY 1ML FROM THE PROBE ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM AFTER REINITIALIZING THE SAM (SAMPLE ACCESS MODULE) AND RUNNING THE FIRST SAMPLE. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND ASPIRATE PROBE ERROR MESSAGES WERE RECEIVED IN CONNECTION WITH THE EVENT. 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
    170333 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1