BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3180904 · Received June 20, 2013

    Report

    Report Number
    1061932-2013-01233
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    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) OPENED THE RIGHT SIDE OF THE INSTRUMENT PANEL AND DISCOVERED A HOLE IN THE BLACK I-BEAM TUBING WHICH CAUSED THE FLUID LEAK. THE FSE REPLACED THE TUBING AND PERFORMED MULTIPLE TESTS SUCCESSFULLY. SERVICE ACTIVITY WAS VERIFIED TO MEET SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLENZ CLEANER SOLUTION LEAKED ONTO THE COUNTER WHILE PERFORMING SYSTEM STARTUP INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE CUSTOMER DISCONTINUED USE OF THE INSTRUMENT AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279653 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1