BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2250559 · Received September 16, 2011

    Report

    Report Number
    1061932-2011-01455
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FLUSHED THE VACUUM PATH FOR THE WASTE CHAMBER WHICH COLLECTS WASTE FROM THE DILUTER. BLOOD, CONTROLS, AND OTHER DEBRIS PASSED THROUGH THE VACUUM PATH. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER COMPLETION OF VERIFIED REPAIRS. THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO THE INSTRUMENT'S WASTE CHAMBER VACUUM PATH NOT FLUSHING.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THE BELLOWS WERE NOT DRAINING PROPERLY AND THERE WAS A LEAK UNDER THE NEEDLE ASSEMBLY OF A COULTER LH 750 HEMATOLOGY ANALYZER. THE HEALTHCARE WORKERS INTERFACING WITH THE MACHINE WERE WEARING PERSONAL PROTECTIVE EQUIPMENT, WHICH INCLUDED LABORATORY COATS AND GLOVES, AT THE TIME OF OCCURRENCE THERE WAS NO BIOHAZARDOUS EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. PATIENT RESULTS WERE NOT AFFECTED BY THIS EVENT. THE CUSTOMER REPEATED PATIENT SAMPLES ON ANOTHER INSTRUMENT AND CONFIRMED THAT THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN RESULTS. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY AND A MATERIAL SAFETY DATA SHEET WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1