MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Model Number	EXACTA24-DYR
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an emc 2400 machine was programmed incorrectly, and the neonate patient became hyperglycemic.On the day of the event the emc 2400 compounder was set with intended volumes of kcl 2meq/ml 3.93ml, nacl 4 meq/ml 1.54ml, dextrose 70% 78.29ml, sterile water 379.43ml, trophamine 10% 78.69ml, naphos 4meq/ml 1.31ml, levocarnitine 200mg/ml 0.2ml, zncl 1mg/ml 0.98ml, mgso4 0.325meq/ml 3.63 ml.However, it appears that dextrose 70% was on port 24 that was intended for sterile water.The bag of total parenteral nutrition (tpn) was sent to the patient unit.The patient was started on peripheral parenteral nutrition with a dose of tpn of with 10% dextrose iv.The following day the patient¿s blood glucose was found to be >500mg/dl.This was assumed to be incorrect, so another blood glucose was obtained, and the results were 3180mg/dl.The tpn infusion was discontinued.The patient was given a one-time dose of 0.316 units of iv insulin then an insulin infusion of 0.05 units/kg/hour.The next day another blood glucose was obtained and found to be 588mg/dl.The lab analyzed the bag and found that the glucose content was approximately 62%.A second sample confirmed the results, indicating a glucose content of about 55%.The samples were diluted by the pharmacy director and manager, and the director took the bag to the lab for further testing, which again confirmed a glucose content of 56%.The patient was not connected directly to the emc 2400; however, the patient received the compounded tpn solution.No further information was available at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h6, h10 and h11.H11: the device was not returned for evaluation; however, the black box files were provided for evaluation.The black box files reveal that the bag was prepared incorrectly, with dextrose 70% on port 24, which was intended for sterile water.Testing of subsequent total parenteral nutrition (tpn) bags showed that the sixth tpn bag and later were correct, but the fourth tpn bag had a higher-than-expected dextrose concentration.The black box shows that the compounder remains setup into the early hours of the morning.On the day in question, the compounder was logged into around 03:00.Per hard programing in the software, if the compounder is used after midnight, the load cell must be recalibrated.This calibration was done at 03:03.A few base bags were made after that calibration.At 09:34 the compounder was shut down.At 10:09 the compounder was powered back on.During this 35-minute gap, it is assumed that they took down the previous day¿s setup and cleaned the compounder.At 10:15 the setup wizard started and at 10:45 the change tube set step of the setup wizard was completed.There was no indication that the first step of the setup wizard, which is calibrate load cell, was performed at this time.Per the additional information provided by the customer, ¿compounder was incorrectly set up, and calibrated with dextrose on the water inlet¿ this event was likely due to a user error; however, without the actual sample the device can not be excluded.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXACTAMIX
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21973690
• Report Number: 1416980-2025-02727
• Device Sequence Number: 9252578
• Product Code: NEP
• UDI-Device Identifier: 00085412609041
• UDI-Public: (01)00085412609041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EXACTA24-DYR
• Device Catalogue Number: EXACTA24DYR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 1 MO
• Patient Sex: Male