BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3945515 · Received July 21, 2014

    Report

    Report Number
    1061932-2014-01665
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED THE LUER LOCK FOR THE RINSE LINE ON THE NEEDLE CARTRIDGE ASSEMBLY WAS CRACKED AND LEAKING. THE FSE REPLACED THE NEEDLE CARTRIDGE RESOLVING THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK IN THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK WAS DESCRIBED AS AN UNKNOWN AMOUNT OF CLEAR FLUID FROM THE RIGHT SIDE OF THE ANALYZER. THE LEAK WAS NOT CONTAINED. THE OPERATOR WAS RUNNING SHUTDOWN/STARTUP WHEN THE LEAK WAS DISCOVERED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF A LAB COAT AND GLOVES AT THE TIME OF THE OCCURRENCE. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO THE USER OR PATIENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424365 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1