BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2984172 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00318
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE SECONDARY PROBE WAS LEAKING FLUID. THE FSE CLEANED THE BLOOD SAMPLING VALVE (BSV) AND CLEANED UP THE DRIED DILUENT. THE FSE PERFORMED SYSTEM SHUTDOWN, STARTUP, AND COMPLETED SAMPLE ANALYSES WITH NO EVIDENCE OF FLUID LEAK. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLEANER FLUID LEAKED FROM THE MANUAL SAMPLE PROBE AND ONTO THE COUNTER INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER NOTICED THE FLUID LEAK AFTER COMPLETING SYSTEM RESET AND SYSTEM NOT READY MESSAGE DISPLAYED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT SAMPLES WERE NOT ANALYZED AT THE TIME OF THE EVENT. THE CUSTOMER HAS A RISK MANAGEMENT PLAN AT THE FACILITY. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86488 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1