BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2435142 · Received February 1, 2012

    Report

    Report Number
    1061932-2012-00219
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 7, 2012
    Report Date
    January 7, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    Z-3123-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SAMPLE PROBE RINSE COLLAR OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WAS LEAKING. CUSTOMER REPORTED THAT ABOUT 30 ML OF DILUTED BLOOD HAD LEAKED IN THE IMMEDIATE AREA. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND A LEAK AT THE PROBE WIPE. THE FSE NOTICED THAT THE WASH TROTH WAS BEING RESTRICTED BY THE TUBING THUS CAUSING THE TROTH PROBE TO NOT WASH PROPERLY. THE FSE READJUSTED THE TROTH AND THE TUBING. THE FSE VERIFIED THE REPAIRS WERE PERFORMED PER ESTABLISHED PROCEDURES.

    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