BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2252105 · Received September 16, 2011

    Report

    Report Number
    1061932-2011-01481
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE FOUND THE TUBING CARRYING DILUENT TO THE HEMOGLOBIN CUVETTE TO BE LEAKING. THE FSE WAS UNABLE TO IDENTIFY WHAT CAUSED THE TUBING TO LEAK. THE FSE REPLACED THE TUBING AND THE LEAKING STOPPED. REPAIRS WERE VERIFIED AS PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SMALL AMOUNT OF CLENZ SOLUTION LEAK UNDER A COULTER LH 780 HEMATOLOGY ANALYZER SINCE A PREVENTIVE MAINTENANCE WAS PERFORMED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES AT THE TIME OF INCIDENT. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO IMPACT TO SAMPLE RESULTS AS A RESULT OF THIS EVENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1