BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF HEMATOLOGY ANALYZER

    MDR report key: 2873899 · Received December 14, 2012

    Report

    Report Number
    1061932-2012-02806
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER ACT DIFF HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 500 ML OF CLEAR FLUID UNDERNEATH THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE OCCURRENCE. THERE IS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO REPORT OF INJURY OR EXPOSURE, AND MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION TO THE LEAK. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND THAT THE LEAK WAS CAUSED BY THE PERISTALTIC TUBING NOT BEING STRETCHED ENOUGH. THE ANALYZER HAD BEEN INSTALLED RECENTLY, AND ANOTHER FSE SERVICED THE CUSTOMER INSTRUCTING HOW TO REPLACE VARIOUS PARTS. THE FSE BELIEVES THE PUMP TUBING MAY NOT HAVE BEEN RE-SEATED AND RE-STRETCHED CORRECTLY AT THAT TIME. THE FSE VERIFIED THE SERVICE ACTIVITY PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. ACT DIFF 16 PARAMETERS NA

    Patients

    Seq Age Sex Outcome Treatment
    1