BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3163523 · Received June 11, 2013

    Report

    Report Number
    1061932-2013-01063
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND CONFIRMED THE LEAK REPORTED BY THE CUSTOMER. THE FSE INDICATED THAT THE NEEDLE ASSEMBLY SEALS WERE BROKEN, WHICH WAS CAUSING CLENZ TO LEAK OUT OF THE NEEDLE. THE FSE REPLACED THE NEEDLE ASSEMBLY, RESOLVING THE LEAK. FAILURE MODE OF THE LEAK WAS RELATED TO BROKEN SEALS ON THE NEEDLE ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ABOUT 4 ML OF BLUE FLUID LEAKED UNDER THE ROCKERBED OF THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT 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, GOGGLES AND A LABORATORY COAT AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS. 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
    264620 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1