BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3260411 · Received August 1, 2013

    Report

    Report Number
    1061932-2013-01605
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 15, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND CONFIRMED THE LEAK FROM SPLIT TUBING FROM THE LOWER SHEATH TANK TO FLOW CELL. THE FSE REPLACED THE TUBING, RESOLVING THE LEAK. FAILURE MODE OF THE LEAK WAS ATTRIBUTED TO SPLIT TUBING FROM THE LOWER SHEATH TANK TO FLOW CELL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT AN UNKNOWN AMOUNT OF LIQUID WAS LEAKING NEAR THE LASER IN THE COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. 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 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
    360634 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1