BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTA-MIX 2400

    MDR report key: 1422977 · Received July 17, 2009

    Report

    Report Number
    1419106-2009-00017
    Event Type
    Other
    Date Received
    July 17, 2009
    Date of Event
    May 5, 2009
    Report Date
    June 18, 2009
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHING THE INLETS TO THE CORRECT PORTS IS A HUMAN FACTOR THAT NEEDS TO BE CONFIRMED DURING THE SETUP PROCESS. THE EM2400 SOFTWARE WAS DESIGNED TO REQUIRE AN INDEPENDENT DOUBLE CHECK OF THE SETUP DURING A PRIME AND VERIFICATION PROCESS. TO ENSURE THAT THE INLET IS ATTACHED TO THE CORRECT PORT, USERS OF THE EM2400 COMPOUNDER ARE TRAINED TO PHYSICALLY GRAB THE INLET THAT IS BEING PRIMED AND VERIFIED AND HOLD ON TO IT AS THE INGREDIENT IS SELECTED FOR PRIMING. THIS PROVIDES A VISUAL VERIFICATION THAT THE INGREDIENT BEING PRIMED IS ACTUALLY PUMPING THROUGH THE INLET THAT IS BEING HELD IN HAND. TO PREVENT THIS ISSUE FROM RE-OCCURRING, THE IMPORTANCE OF THE VERIFICATION PROCESS DURING THE SETUP OF THE EM2400 COMPOUNDER WAS REVISITED WITH ALL STAFF. RE-TRAINING WAS PROVIDED IN ACCORDANCE WITH THE EM2400 TECHNICAL MANUAL AND THE EM2400 TRAINING VIDEO. IN ADDITION, ALL NEW IV ROOM TECHNICIANS MUST PASS THE SETUP, PRIME AND VERIFICATION PROCESS BEFORE OPERATING THE EM2400 COMPOUNDER. ALSO, ONGOING LABORATORY TESTING WILL BE PERFORMED ON THE FIRST TPN BAGS PRODUCED FOR THE DAY. RESULTS: USER/DEVICE INTERFACE. CONCLUSION: DEVICE OPERATED ACCORDING TO SPECIFICATIONS. USER ERROR CAUSED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2009, BAXA WAS NOTIFIED BY THE CUSTOMER OF MULTIPLE PATIENT INVOLVED INCIDENTS USING THE EXACTA-MIX 2400 COMPOUNDER FOR TPN PRODUCTION. IT WAS REPORTED THAT 11 NEONATAL PATIENTS AND 3 PEDIATRIC PATIENTS RECEIVED TPN BAGS WHERE MAGNESIUM WAS PUMPED INSTEAD OF HEPARIN. THE BAGS WERE INFUSED BETWEEN 4 TO 6 HOURS AND TERMINATED ONCE THE ERROR WAS DETECTED IN THE PHARMACY. THE MAGNESIUM LEVELS WERE ELEVATED IN SIX PATIENTS WITH 2.7 BEING THE HIGHEST. HOWEVER, NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED AND NO APPARENT LONG-TERM INJURY OR ILLNESS RESULTED FROM THIS ISSUE. THE FACILITY STATES THAT THEIR STAFF INCORRECTLY SETUP THE EM2400 COMPOUNDER; THE TUBING FOR MAGNESIUM 8% WAS CONNECTED INTO THE PORT ASSIGNED TO HEPARIN 100 UNIT/ML AND VICE VERSA. THERE WERE NO PTS WHO RECEIVED HEPARIN WHO SHOULD HAVE RECEIVED MAGNESIUM. NOTE: THE FACILITY HAS ELECTED TO NOT SUBMIT THE DETAILS FOR EACH PATIENT (AGE, GENDER AND WEIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 EXACTA-MIX 2400 LHI BAXA CORPORATION EM 2400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention