BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3191570 · Received June 26, 2013

    Report

    Report Number
    1061932-2013-01194
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED THAT THE BATHS WERE OVERFLOWING. THE FSE FOUND BLOODY RESIDUE THAT WAS BLOCKING THE OVERFLOW SENSOR. THE FSE CLEARED THE SENSOR AND THE INSTRUMENT RAN WITHOUT ANY LEAKS OR ERRORS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. THE CAUSE OF THE LEAK WAS BLOODY RESIDUE BLOCKING THE OVERFLOW SENSOR OF THE BATHS. HOWEVER, THE INSTRUMENT OPERATED AS INTENDED BY GENERATING THE 'RBC BATH OVERFLOW' ERRORS, ALERTING THE OPERATOR TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK INSIDE THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE INSTRUMENT WAS GIVING RED BLOOD CELL ¿RBC BATH OVERFLOW¿ ERRORS WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS ABOUT 1 ML AND WAS CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THE LABORATORY¿S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. NO ONE CAME IN CONTACT WITH THE FLUID. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO DISCREPANT PATIENT RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291746 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1