BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 5 DIFF CAP PIERCER (CP) ANALYZER

    MDR report key: 3051603 · Received April 10, 2013

    Report

    Report Number
    1061932-2013-00605
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER TO PERFORM TROUBLESHOOTING VIA TELEPHONE. THE CUSTOMER DISCOVERED THAT IT WAS THE SAMPLING SYRINGE LEAKING NOT THE PROBE, WHICH HAD DRIVEN PAST THE START CYCLE SWITCH CAUSING DILUENT TO LEAK FROM THE SAMPLING SYRINGE. THE CUSTOMER WAS INSTRUCTED TO MANUALLY MOVE THE SAMPLING SYRINGE THEN RESET THE INSTRUMENT TO CORRECT THE ISSUE. THIS RESOLVED THE LEAK. THE ASPIRATION PROBE AS INITIALLY REPORTED WAS NOT ASSOCIATED WITH THE LEAK. FAILURE MODE IS RELATED TO THE SAMPLING SYRINGE. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A LEAK OF APPROXIMATELY 1 ML OF DILUENT COMING FROM THE PROBE ASSEMBLY ON TOP OF THE BATH COVER OF THE COULTER ACT 5 DIFF CAP PIERCER (CP) ANALYZER WHILE RUNNING PATIENT SAMPLES. NO PATIENT RESULTS WERE PRODUCED FOR THE FIRST PATIENT SAMPLE RUN; THE CUSTOMER OBTAINED ALL ZEROS FOR ALL PARAMETERS. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153243 COULTER AC*T 5 DIFF CAP PIERCER (CP) ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T 5 DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1