BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3852385 · Received June 5, 2014

    Report

    Report Number
    1061932-2014-01213
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND A HOLE IN TUBING GOING TO VALVE VL242 IN MANIFOLD 201 WHICH LEAKED FLUID INTO THE AIR MIX AND TEMPERATURE CONTROL (AMTC) CHAMBERS. THE FSE REPLACED THE TUBING GOING TO VALVE VL242 AND THE DIFFERENTIAL CHAMBER. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 10 MLS OF CLENZ AND SAMPLE LEAKED IN THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328651 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1