BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2951105 · Received February 8, 2013

    Report

    Report Number
    1061932-2013-00138
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BEC CUSTOMER TECHNICAL SPECIALIST (CTS) WORKED WITH THE CUSTOMER TO DETERMINE THE SOURCE OF THE LEAK. THE CTS HAD THE CUSTOMER CLEAN THE RBC BATH DRAIN LINE WITH BLEACH 4 TIMES, RINSE THE BATH WITH DISTILLED WATER, RAN STARTUP AND CONTROLS. ALL PARAMETERS MET THE SPECIFICATIONS AND THE RBC BATH DRAINED PROPERLY WHICH RESOLVED THE LEAK. FAILURE MODE OF THIS EVENT WAS RBC BATH OBSTRUCTED WITH UNKNOWN MATERIAL. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT WHILE RUNNING CONTROLS ON THE COULTER ACT DIFF ANALYZER, THEY NOTICED THAT HE RED BLOOD CELL (RBC) BATH WAS OVERFLOWING ONTO THE COUNTER UNDER THE INSTRUMENT. THE VOLUME WAS REPORTED TO BE APPROXIMATELY ONE CUP OF FLUID. THE RBC BATH DRAIN TUBING MAY CONTAIN LYSE, BLOOD AND DILUENT WHILE IN OPERATION AND CLEANER WHILE IN SHUTDOWN. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES ONLY. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. NO PATIENT RESULTS WERE AFFECTED. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54074 COULTER® ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1