BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3171768 · Received June 17, 2013

    Report

    Report Number
    1061932-2013-01113
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND A LEAK COMING FROM FLOWCELL SHEATH FLOW PORT #5 TUBING AND REPLACED THE TUBING. THE FSE CLEANED THE AREA, INSURED THERE WERE NO OTHER LEAKS. THE FSE RAN CONTROLS AND MULTIPLE PATIENT SAMPLES WITH ACCEPTABLE RESULTS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES; RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. FAILURE MODE WAS ATTRIBUTED TO THE FLOWCELL PORT #5 TUBING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEIR COULTER LH 780 HEMATOLOGY ANALYZER WAS LEAKING NEAR THE DIFFERENTIAL MIXING CHAMBER. THE CUSTOMER INDICATED THAT THEY SEARCHED FOR THE LEAK, BUT THEY WERE UNABLE TO FIND THE EXACT SOURCE OF THE LEAK. THE LEAKING LIQUID WAS CLEAR, AND WAS NOT CONTAINED WITHIN THE ANALYZER AND SPILLED ALL OVER THE COUNTER. THE VOLUME WAS ABOUT 2 CUPS. THE LEAK DID NOT AFFECT SAMPLE OR REAGENT INTEGRITY. THERE WAS NO CROSS CONTAMINATION. IT DID NOT IMPACT ELECTRICAL OR OPTICAL PERFORMANCE. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE CUSTOMER WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO CONTACT WITH SKIN, MUCOUS MEMBRANES, OR OPEN WOUNDS. NO MEDICAL ATTENTION WAS SOUGHT. NO SAMPLE RESULTS WERE AFFECTED. NO ERRONEOUS RESULTS WERE GENERATED. ALL SAMPLES WERE RERUN ON THEIR OTHER ANALYZER TO CONFIRM RESULTS WERE ACCURATE. THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273228 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1