BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 2140227 · Received June 26, 2011

    Report

    Report Number
    1061932-2011-00744
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR EVENT AND FOUND DISPENSE PROBE TUBING LEAKING. THE LEAKAGE WAS CLEANED AND THE TUBING REPLACED. REPAIRS PER ESTABLISHED PROCEDURES WERE VERIFIED AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE FOR THE LEAK IS ASSOCIATED WITH THE TUBING IN THE DISPENSE PROBE MECHANISM WHICH WAS REPLACED. PER LABELING, BECKMAN COULTER 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A FLUID LEAK (BLOOD) DRIPPING INTO THE LOWER DRIP TRAY IN THE COULTER LH 750 SLIDEMAKER. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT AND WAS NOT EXPOSED TO ANY BIOHAZARD MATERIAL. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPENWOUNDS. 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 750 SLIDEMAKER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. TN, LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1