BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH SLIDEMAKER

    MDR report key: 2511906 · Received March 30, 2012

    Report

    Report Number
    1061932-2012-01084
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 7, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE RED STRIPE PINCH VALVE TUBING ON DISPENSE PROBE WAS CUT AND BLOOD WAS SPRAYED INSIDE THE SLIDEMAKER. THE FSE REPLACED THE DISPENSE PROBE PINCH VALVE, PINCH VALVE MOUNT, ACTUATOR, AND PINCH VALVE TUBING. THE FSE REMOVED SEVERAL SECTIONS/MODULES AND CLEANED THE FLUID LEAK. HOUSEHOLD BLEACH WAS USED TO CLEAN AND DISINFECT SURFACES. THE UNIT CONFORMED TO THE MANUFACTURER'S PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SMALL AMOUNT OF FLUID, CONSISTED OF BLOOD, LEAKED INSIDE NEAR THE RESERVOIR ROD INVOLVING LH SLIDEMAKER. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT (PPE) PRIOR TO TROUBLESHOOTING. THE CUSTOMER HAD ON A LABORATORY COAT AND GLOVES PRIOR TO TROUBLESHOOTING. THE CUSTOMER NOTED THE FLUID LEAKED AT THE PINCH VALVE NEAR THE RESERVOIR ROD AND ONTO THE COUNTERTOP. THE CUSTOMER FOLLOWED THE EXPOSURE CONTROL/RISK MANAGEMENT PLAN AND CLEANED UP THE SPILL. NO PATIENT RESULTS WERE IMPACTED. THE CUSTOMER DID NOT COME INTO 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 EVENT. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1