BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2970680 · Received February 20, 2013

    Report

    Report Number
    1061932-2013-00251
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF CLEAR FLUID FROM THE ASPIRATION PUMP INSIDE THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER INDICATED THAT APPROXIMATELY 3 MLS OF FLUID HAD LEAKED BUT WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO AFFECT OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPLACED THE PRIMARY ASPIRATION PUMP AND VERIFIED THE ASPIRATION VOLUME. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74590 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1