BEUDAMED
    FDA Adverse Event Summary report: N

    EXACTAMIX¿ 2400

    MDR report key: 2873816 · Received December 14, 2012

    Report

    Report Number
    1419106-2012-00020
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EM2400 COMPOUNDER IS AN AUTOMATED COMPOUNDING DEVICE (ACD) THAT STREAMLINES MULTI-SOURCE MIXING APPLICATIONS FOR PHARMACIES. OUR INVESTIGATION HAS SHOWN THAT THE EM2400 COMPOUNDER OPERATED AS INTENDED: THE INCIDENT WAS NOT CAUSED BY IMPROPER PREPARATION OF THE BAG, BUT RATHER IT WAS DUE TO HUMAN ERROR CAUSED BY THE PATIENT CARE STAFF. THE CUSTOMER REPORTED THAT THE BAG WAS CLEARLY LABELED WITH THE PATIENT'S NAME HIGHLIGHTED, BUT THE NURSE FAILED TO ASSOCIATE THE TPN TO THE CORRECT PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED SOME HYPONATREMIA (A COMMON ELECTROLYTE DISORDER ASSOCIATED WITH A NUMBER OF CLINICAL CONDITIONS) AND CONFUSION, BUT, PER THEIR PROTOCOL, THEY HUNG A LOWER CONCENTRATION OF DEXTROSE (D5NS) AND THE PATIENT IS STABLE AND FINE. THE PATIENT CARE STAFF HAS BEEN RETRAINED IN THEIR PROCEDURES FOR HANGING TPNS. BAXA RISK DOCUMENTATION WAS REVIEWED AND IT WAS DETERMINED THAT THE REPORTED ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED FOR THE DEVICE; HOWEVER, THIS ISSUE WILL CONTINUE TO BE MONITORED PER BAXA TREND ANALYSIS PROCEDURES. METHOD: TESTING WAS NOT PERFORMED ON THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, WE BECAME AWARE OF AN EVENT WHERE THE CUSTOMER REPORTED THAT A NURSE ON THE FLOOR HUNG AN INCORRECT BAG FOR AN ADULT PATIENT. THE BAG HAD BEEN COMPOUNDED WITH THE USE OF A BAXA EM2400 COMPOUNDER (THE EM2400 COMPOUNDER IS AN AUTOMATED COMPOUNDING DEVICE (ACD) THAT STREAMLINES MULTI-SOURCE MIXING APPLICATIONS FOR PHARMACIES) AND WAS ADMINISTERED FOR APPROXIMATELY 30 MINUTES BEFORE ANOTHER NURSE CAUGHT THE ERROR AND STOPPED THE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX¿ 2400 EM2400 NEP BAXA CORPORATION 2400-M

    Patients

    Seq Age Sex Outcome Treatment
    1