BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4222082 · Received November 3, 2014

    Report

    Report Number
    1061932-2014-02753
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DID NOT OBSERVE AND COULD NOT DUPLICATE THE FLUID LEAK REPORTED BY THE CUSTOMER. THE FSE REPLACED SOLENOID 17 (LV17) TO RESOLVE THE PARTIAL ASPIRATION AND BACKWASH NOT PERFORMED SYSTEM ERRORS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 30 MILLILITERS OF CLEAR FLUID LEAKED INSIDE THE INSTRUMENT DURING QUALITY CONTROL INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE GLASSES AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE FACILITY HAS AN EXPOSURE CONTROL PLAN IN PLACE FOR BIOHAZARD MATERIAL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702117 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1