BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 750 SLIDEMAKER

    MDR report key: 2591117 · Received May 29, 2012

    Report

    Report Number
    1061932-2012-01694
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 7, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND A LEAK IN THE TUBING AT VALVE VL20. HE REPLACED THE TUBING TO RESOLVE THE PROBLEM. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO SERVICE. THE FAILURE MODE WAS A LEAK IN THE TUBING AT THE VL20 VALVE. UPON RECUR, THIS FAILURE MODE WOULD NOT HAVE THE POTENTIAL TO CAUSE DISCREPANT RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPROXIMATELY TWENTY MILLILITERS OF AN UNKNOWN BLUE-GREEN LIQUID HAD LEAKED FROM UNDER THE TRAYS OF A LH 750 SLIDEMAKER. THE LEAK WAS NOT CONTAINED TO THE INSTRUMENT AND HAD SPILLED ON THE COUNTER. THE HEALTHCARE WORKER INTERFACING WITH THE MACHINE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT WHICH INCLUDED A LABORATORY COAT AND GLOVES. THERE WAS NO EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURY WAS REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. THE INSTRUMENT STOPPED MAKING SLIDES UPON ONSET OF LEAK. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. NO DEATH OR INJURY WAS ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY AND THE MATERIAL SAFETY DATA SHEET WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH 750 SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1