BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 12? ANALYZER

    MDR report key: 3133851 · Received May 29, 2013

    Report

    Report Number
    1061932-2013-00980
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PINCH TUBING AT PINCH VALVE VL8 TO CORRECT THE FLUID LEAKING ISSUE. THE FSE PERFORMED A VERIFICATION INSPECTION REPORT (VIP) ON THE INSTRUMENT. THE FSE NOTICED THE DILUENT AND SAMPLE SYRINGE WERE LEAKING AND REPLACED THE DILUENT AND SYRINGE. THE FSE ALSO NOTICED THE PROBE WIPE WAS CORRODED AND REPLACED THE PROBE WIPE. AFTER COMPLETING VIP, THE FSE DISCOVERED PINCH VALVE LV15 WAS NO LONGER FUNCTIONING AND REPLACED THE PINCH VALVE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. PROBE WIPE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY TEN TO TWENTY MILLILITERS OF FLUID LEAKED OUTSIDE THE INSTRUMENT AND ONTO THE COUNTER FROM THE COULTER ACT DIFF 12¿ ANALYZER DURING SYSTEM STARTUP. THE OPERATOR WAS WEARING PROTECTIVE GLOVES AT THE TIME OF THE EVENT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED, AND THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235558 COULTER® ACT DIFF 12? ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1