BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2830796 · Received November 13, 2012

    Report

    Report Number
    1061932-2012-02703
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012, TO ADDRESS THIS ISSUE. THE FSE OBSERVED DRIED LH CLEANER VISIBLE INSIDE RIGHT SIDE DOOR OF ANALYZER AND FOUND SMALL HOLE IN BLACK STRIPPED TUBING ROUTED THROUGH PINCH VALVE PV42. THE FSE REPLACED THE BLACK STRIPPED TUBING IN PV42 AND PERFORMED SHUT DOWN AND STARTUP TO CONFIRM NO MORE LEAKAGE. FAILURE MODE: ATTRIBUTED TO A HOLE IN TUBING ROUTED THROUGH PINCH VALVE PV42. 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) REPORTING A LEAK (APPEARED TO BE LH CLEANER) FROM THE TUBING BELOW THE VACUUM REGULATOR, IN THE MAIN DILUTER, AND LEAKED ONTO THE TABLE UNDER THE COULTER LH 500 INSTRUMENT, WHICH WAS NOT RUNNING WHEN THE LEAK WAS OBSERVED. THE LEAK WAS NOT CONTAINED THE OPERATOR WAS WEARING A LAB COAT AND GLOVES BUT NO EYE PROTECTION AT THE TIME THE LEAK WAS DISCOVERED. THERE IS AN EXPOSURE CONTROL PLAN. THE LEAK DID NOT AFFECT SAMPLE INTEGRITY AND THERE WAS NO CROSS CONTAMINATION. THE LEAK DID NOT IMPACT ELECTRICAL OR OPTICAL PERFORMANCE OF THE UNIT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB AND THE LEAK DID NOT AFFECT SAMPLE RESULTS. THERE WAS NO DIRECT BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1