BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3972117 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01804
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ANALYZER AND FOUND WORN TUBING AT PINCH VALVE PV40. THE FSE REPLACED TUBING AT PV40 AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK IN THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK ORIGINATED FROM THE INSIDE RIGHT COMPARTMENT OF THE INSTRUMENT. THE VOLUME OF THE LEAK WAS APPROXIMATELY 10ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE ANALYZER WAS RUNNING SAMPLES AT THE TIME THE LEAK WAS IDENTIFIED. 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 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 TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447706 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1