BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3920376 · Received July 8, 2014

    Report

    Report Number
    1061932-2014-01552
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 LEAK WAS FROM THE SWEEP FLOW TANK LINE TUBING. THE FSE ALSO IDENTIFIED THE PRESSURE LINE TUBING WAS DISCONNECTED FROM THE DIFF (DIFFERENTIAL) MIX CHAMBER, AND AS A RESULT, NO DIFFERENTIAL RESULTS WERE BEING RECOVERED. THE FSE REPLACED THE SWEEP FLOW LINE TUBING, FIXING THE LEAK AND THE LOW VACUUM ERRORS. THE FSE ALSO REPLACED THE PRESSURE LINE TUBING TO RESOLVE THE ISSUE WITH THE DIFFERENTIAL TEST RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK IN THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK WAS 1 ML OF FLUID AND WAS CONTAINED WITHIN THE INSTRUMENT. THE LEAK WAS IDENTIFIED BY THE CUSTOMER AFTER AN ERROR CONDITION OF "LOW VACUUM" WAS GENERATED AND THE CUSTOMER INITIATED A SYSTEM TEST. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES, EYE PROTECTION, AND A LAB COAT 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
    397518 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1