BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH SLIDEMAKER

    MDR report key: 2596493 · Received June 1, 2012

    Report

    Report Number
    1061932-2012-01804
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED FLUID LEAKED AT LINE VL8 ON THE ASPIRATION MODULE DUE TO DAMAGED TUBING. THE FSE CLEANED THE LEAK AREA AND REPLACED THE TUBING ON LINE VL8 IN THE DISPENSE MODULE. THE FSE PERFORMED FLUIDIC FLOW CHECKS AND NOTED NO FURTHER LEAKS. THE FSE COMPLETED AN ADDITIONAL MINOR PREVENTIVE MAINTENANCE (PM) INCLUDING SLIDE-MAKING CHECKS, NO ISSUES WERE NOTED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER HAS AN EXPOSURE CONTROL MANAGEMENT PLAN AT THE FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY FIVE (5) MILLILITERS OF BLOOD AND DILUENT LEAKED WITHIN THE INSTRUMENT INVOLVING COULTER LH SLIDEMAKER. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION DURING THE INCIDENT. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCUS MEMBRANES. THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS INCIDENT. THE CUSTOMER RETESTED EIGHT (8) PATIENT SAMPLES AND CONFIRMED PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS INCIDENT. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1