BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750 SLIDEMAKER

    MDR report key: 2508103 · Received March 28, 2012

    Report

    Report Number
    1061932-2012-00906
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC (BEC) THAT THERE WAS A LEAK OF BLOODY FLUID DRIPPING INTO THE SLIDE TRAY ON THE COULTER LH750 SLIDEMAKER. THE OPERATOR WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE MATERIAL SAFETY DATA SHEET WAS NOT REVIEWED, BUT AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IS IN PLACE. THERE WAS NO IMPACT TO PATIENT RESULTS. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. FIELD SERVICE ENGINEER (FSE) FOUND THAT THE VACUUM ACCUMULATOR TANK DRAIN LINE WAS KINKED BETWEEN THE HINGE BACK DOOR AND THE FRAME OF THE SLIDE-MAKER. THE FSE REPLACED THE DRAIN LINE AND RESOLVED THE LEAK. REPAIRS WERE VERIFIED AS PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE VACUUM ACCUMULATOR TANK DRAIN LINE MAY HAVE BLOOD AND DILUENT WHILE IN OPERATION AND CLEANER WHILE IN SHUTDOWN. THE CAUSE OF THE LEAK WAS VACUUM ACCUMULATOR TANK DRAIN LINE KINKED BETWEEN THE HINGE BACK DOOR AND THE FRAME OF THE SLIDE-MAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH750 SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1