BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH500 HEMATOLOGY ANALYZER

    MDR report key: 3033697 · Received April 3, 2013

    Report

    Report Number
    1061932-2013-00498
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER LH500 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 200ML OF CLEANING AGENT (CLENZ) ONTO THE COUNTER. THE CUSTOMER WAS WEARING A LAB COAT, EYE WEAR, AND GLOVES AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER DID NOT REVIEW THE MATERIAL SAFETY DATA SHEET (MSDS), BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN IN PLACE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE LEAK WAS FROM THE DISCONNECTED TUBING AT THE PINCH VALVE (PV) 30. THE FSE RECONNECTED THE TUBING AND RESOLVED THE LEAK. THE FSE FOUND THAT THE LEAK HAD DAMAGED THE CABLE CONNECTOR, WHICH MADE THE INSTRUMENT INOPERABLE. THE FSE PERFORMED A PREVENTIVE MAINTENANCE AND RESOLVED ALL INSTRUMENT ISSUES PER ESTABLISHED PROCEDURES. THE FSE VERIFIED THE SERVICE ACTIVITY PERFORMED PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135677 COULTER® LH500 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1