BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2230276 · Received September 1, 2011

    Report

    Report Number
    1061932-2011-01332
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND INDICATED THAT THE INSTRUMENT WAS EXPERIENCING AN 'INCOMPLETE TUBE RETRACT ERROR' AS WELL AS THE FLUID LEAK. THE LEAK OCCURRED WHEN THE INSTRUMENT WAS GOING INTO SHUTDOWN MODE AND CLENZ WAS RUNNING THROUGH THE SYSTEM. TUBING RUNNING THROUGH PINCH VALVE 42 WAS FOUND TO BE LEAKING. THE TUBE FORWARD SENSORS WERE CLEANED AND ADJUSTED BY THE FSE. THE FSE ALSO CHECKED THE ELECTRICAL CONNECTORS AND CYLINDER TUBE RAM. THE LEAK ISSUE WAS RESOLVED AND INSTRUMENT IS RUNNING AS PER PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE LEAK WAS THE TUBING AT PINCH VALVE 42 ON THE MAIN DILUTER MODULE. AS PER PRODUCT LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THERE WAS A CLENZ LEAK (ABOUT 5-10 CUBIC CENTIMETERS OF FLUID) ON THE COULTER LH 500 INSTRUMENT. THE CUSTOMER WAS NOT PRESENT AT THE TIME OF THE DISCOVERY BUT STATED IT WAS LIKELY THAT THE TECHNICIAN WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). NEITHER THE CUSTOMER NOR THE TECHNICIAN CAME IN CONTACT WITH THE FLUID. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED, SPRAYED, OR INJURED. THERE WAS NO IMPACT TO SAMPLE RESULTS BY THIS EVENT. THE LEAK OCCURRED DURING SHUT DOWN OF THE INSTRUMENT AND WHEN A ''FORWARD RETRACT ERROR'' OCCURS, THE ANALYZER STOPS RUNNING AND WILL NOT PROCESS. THE INPUT TUBING LINE WAS CARRYING CLENZ AT THE TIME OF THE MALFUNCTION. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 INSTRUMENT AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1