BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3093296 · Received May 6, 2013

    Report

    Report Number
    1061932-2013-00748
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 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
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND CONFIRMED A CONTAINED CLENZ LEAK. THE FSE REPLACED A WORN TUBING AT PINCH VALVE (PV37), RESOLVING THE LEAK. THE FSE COMPLETED A FLOW CELL ALIGNMENT TO RESOLVE THE LATRON CONTROL RECOVERY. THE FAILURE MODE WAS RELATED TO WORN TUBING THROUGH PV37 AND TO ALIGNMENT OF THE FLOW CELL WHICH CAUSED THE LATRON CONTROL TO BE OUT FOR THE VOLUME CHANNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT LESS THAN 2 ML OF CLENZ WAS LEAKING FROM THE RIGHT HAND SIDE DILUTER CENTER PANEL OF THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE FLUID HAD LEAKED ONTO THE TRIPLE TRANSDUCER MODULE (TTM) PLASTIC COVER. THE CUSTOMER ALSO REPORTED THE LATRON VOLUME WAS LOW AT 24.1. 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 PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, FACE PROTECTION AND A LABORATORY COAT WHEN THE LEAK WAS OBSERVED. 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
    196084 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1