BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH780 HEMATOLOGY ANALYZER

    MDR report key: 3053388 · Received April 11, 2013

    Report

    Report Number
    1061932-2013-00554
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE COULTER LH 780 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 5 TO 10 ML OF FLUID AROUND THE FLOW CELL. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THE CUSTOMER DID NOT REVIEW THE MATERIAL SAFETY DATA SHEET BUT HAS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THEREFORE THERE WAS NO IMPACT TO PATIENT TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) OBSERVED A LEAK COMING FROM DILUENT TUBING AT DIFF MIX CHAMBER AREA. THE FSE REPLACED THE TUBING AND CLEANED THE AFFECTED AREA. NO FURTHER LEAKS WERE OBSERVED. THE FSE NOTED THE TUBING WAS SHEATH RESTRICTOR TUBING THAT SUPPLIES DILUENT TO THE FLOW CELL. THE FSE VERIFIED THE SERVICE ACTIVITY PERFORMED PER ESTABLISHED PROCEDURES AND THE RESULTS MET THE PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154220 COULTER® LH780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1