BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER

    MDR report key: 3090630 · Received May 2, 2013

    Report

    Report Number
    1061932-2013-00738
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE COULTER HMX HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 30ML OF DILUENT. THE LEAK WAS FROM THE RIGHT SIDE OF THE INSTRUMENT AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES. THE CUSTOMER WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE OCCURRENCE. THERE WAS NO INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER DID NOT REVIEW THE MATERIAL DATA SAFETY SHEET (MSDS), BUT HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THE EVENT. BEC FIELD SERVICE ENGINEER (FSE) INDICATED THAT THERE WAS A CLENZ (CLEANING AGENT) LEAK FROM BOTTOM OF THE INSTRUMENT. THE FSE REPLACED TUBING AT SWEEP FLOW FOAM TRAP CHAMBER AND RESOLVED THE LEAK. THE FSE VERIFIED THE SERVICE ACTIVITY PERFORMED PER ESTABLISHED PROCEDURES AND THE RESULTS MET THE PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192485 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER HMX AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1