BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3232868 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01478
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 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
    OH, 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 THE HGB LAMP WAS OPERATIONAL AND THE LEAK WAS A RESULT OF DISCONNECTED TUBING OFF VL61 (BACKWASH TANK/SWEEP FLOW RESERVOIR PURGE). THE FSE REPLACED THE TUBING RESOLVING THE LEAK AND VERIFIED THAT THE HGB CUVETTE ASSEMBLY WAS OPERATIONAL TO ENSURE PROPER HGB RESULTS. SERVICE ACTIVITY WAS PERFORMED AND WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. FAILURE MODE WAS ATTRIBUTED TO DISCONNECTED TUBING OFF THE VL61 (BACKWASH TANK/SWEEP FLOW RESERVOIR PURGE). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE HEMOGLOBIN (HGB) LAMP WAS NOT WORKING AND APPROXIMATELY 10 ML OF DILUENT WAS LEAKING FROM THE BACKWASH TANK/SWEEP FLOW RESERVOIR PURGE (VL61) OF THE COULTER LH 780 HEMATOLOGY ANALYZER AND ONTO THE COUNTER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE ANALYZER WAS ALSO NOT PRODUCING HGB RESULTS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334199 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1