BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5DIFF CAP PIERCE (CP)

    MDR report key: 2960133 · Received February 13, 2013

    Report

    Report Number
    1061932-2013-00223
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEAR FLUID LEAK OF APPROXIMATELY 20 ML FROM UNDERNEATH A COULTER ACT 5DIFF CAP PIERCE (CP). THE IDENTITY OF THE FLUID IS UNKNOWN AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LAB COAT AND GLOVES AND NO EXPOSURE OR INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND A CORRODED AND PITTED REAGENT SYRINGE DRIVE ASSEMBLY WHICH CAUSED THE LEAK. THE FSE REPLACED THE REAGENT SYRINGE DRIVE ASSEMBLY AND THE REAGENT SYRINGE AND THE LEAK WAS RESOLVED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63683 COULTER® ACT 5DIFF CAP PIERCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1