BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3031771 · Received April 2, 2013

    Report

    Report Number
    1061932-2013-00556
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    H3: THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE SOURCE OF THE FLUID LEAK AT THE BLOOD SAMPLING VALVE (BSV). THE FSE NOTED THE SPRING ON THE KNOB OF THE BSV WAS BROKEN WHICH CAUSED THE BSV TO SLIGHTLY SEPARATE AND LEAK. THE FSE REPLACED THE ACTUATOR AND RESOLVED THE FLUID LEAK ISSUE. NO FURTHER FLUID LEAK WAS OBSERVED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED APPROXIMATELY TWENTY (20) MILLILITERS OF CLEAR FLUID LEAKED FROM UNDERNEATH THE INSTRUMENT AND ONTO THE FLOOR INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. QUALITY CONTROL (QC) WAS WITHIN RANGE AT THE TIME OF THE EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE LABORATORY HAS AN EXPOSURE CONTROL PLAN IN PLACE, AND THE INSTRUMENT WAS NOT IN OPERATION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133676 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1