BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT? 5DIFF CAP PIERCE (CP)

    MDR report key: 3163632 · Received June 11, 2013

    Report

    Report Number
    1061932-2013-01145
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE REAGENT SYRINGE WAS LEAKING AT THE RINSE AND HEMOGLOBIN PISTONS. THE FSE REPLACED THE REAGENT SYRINGE BUT THE FLUID LEAK CONTINUED. THE FSE REMOVED THE REAGENT SYRINGE AND MOTOR ASSEMBLIES AND CLEANED THE DEPOSIT FROM THE MOTOR SYRINGE METAL INTERFACE CONNECTOR TO THE PISTONS. THE FSE INSTALLED THE REAGENT SYRINGE AND MOTOR ASSEMBLIES AND NOTED THE LEAK EMANATING FROM THE FRONT OF THE RINSE PISTON ONLY, INDICATING THE RINSE PISTON WAS NOT PERPENDICULAR TO THE METAL INTERFACE CONNECTOR. THE FSE REMOVED THE REAGENT SYRINGE ASSEMBLY AND BENT THE METAL CONNECTOR UPWARDS AT THE FRONT AND REINSTALLED THE REAGENT SYRINGE ASSEMBLY AND PRIMED THE RINSE REAGENT IN GRADUATED AMOUNTS UNTIL THE FLUID LEAK STOPPED. THE FSE PRIMED ALL REAGENTS AND NOTED NO FLUID LEAKS WERE PRESENT. THE FSE COMPLETED SUCCESSFUL REPRODUCIBILITY TEST AND QUALITY CONTROL (QC). THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED APPROXIMATELY FIFTEEN (15) MILLILITERS OF FLUID LEAKED ONTO THE COUNTERTOP INVOLVING THE COULTER ACT 5DIFF CAP PIERCE (CP). THE CUSTOMER NOTED THE FLUID LEAK ORIGINATED FROM ONE OF THE REAGENT SYRINGES. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT 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. 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
    264198 COULTER® ACT? 5DIFF CAP PIERCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1