BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 5348330 · Received January 6, 2016

    Report

    Report Number
    1061932-2016-00018
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    December 13, 2015
    Report Date
    December 13, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON (B)(6) 2015 . THE FSE FOUND A LEAK ON THE MAIN DILUTER CAUSED BY THE TUBING AT PINCH VALVE (PV37). HE REPLACED THE TUBING AND RESOLVED THE LEAK. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FIVE TO TEN ML OF BLUE CLEANER REAGENT LEAKED FROM THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER ON THE RIGHT SIDE NEAR (FEED THROUGH) FITTING FF222. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT, GOGGLES, AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7947 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1