BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2993788 · Received March 8, 2013

    Report

    Report Number
    1061932-2013-00374
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A SMALL AMOUNT OF DRIED BLOOD AT THE BOTTOM OF THE PIERCING MODULE AND CLEANED UP SPILLAGE UTILIZING PERSONAL PROTECTIVE EQUIPMENT (PPE). THE FSE REPLACED THE ASPIRATION TUBING FROM THE NEEDLE TO THE BLOOD DETECTOR (BD1). THE FSE NOTED SLOW FLOW THROUGH THE BLOOD SAMPLING VALVE (BSV) AND DISASSEMBLED AND CLEANED THE BLOOD SAMPLING VALVE. THE FSE PERFORMED SYSTEM STARTUP AND SYSTEM VERIFICATION AND COMPLETED RETAINED PATIENT SAMPLES WITHOUT ERRORS. THE FSE VERIFIED NO FLUID LEAK AT THE NEEDLE AND PIERCING MODULE. 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 APPROXIMATELY FIFTY MILLILITERS OF FLUID LEAKED OUTSIDE THE INSTRUMENT FROM THE SAMPLE LINE THAT HAD COME OFF THE NEEDLE ASSEMBLY INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. 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. PATIENT RESULTS WERE NOT IMPACTED. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100229 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1