BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2477036 · Received March 5, 2012

    Report

    Report Number
    1061932-2012-00772
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THE LEAK AT PINCH VALVE 43(PV43). FSE REPLACED TUBING AT PV43 AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. THERE WAS NO FURTHER EVIDENCE OF LEAKING. THE ROOT CAUSE OF THE LEAK IS ATTRIBUTED TO PV43. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED A LEAK OF APPROXIMATELY 4-5 MLS OF CLEAR FLUID LEAKING FROM THE RIGHT SIDE OF THEIR COULTER HMX AUTOLOADER INSTRUMENT. THE CUSTOMER WAS UNABLE TO PINPOINT THE SOURCE, BUT THE LIQUID WAS CLEAR. THE LAB'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. NO INJURY OR EXPOSURE WAS REPORTED AND NO PATIENT RESULTS WERE AFFECTED; THE UNIT WAS IN A SHUTDOWN AND STARTING A STARTUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. HMX AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1