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

Model Number	EXACTA-M
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a neonatal patient developed hypermagnesemia when an exactamix pharmacy compounding device dispensed too much magnesium.A neonate in the neonatal intensive care unit (nicu) was found to have a magnesium level ¿2.5 times¿ more than the acceptable levels (actual magnesium levels not reported).The order in the hospital electronic system was 0.59ml to be added to the total parenteral nutrition bag.The lab tested the bag four times with an average value of 179.44 mg/100ml.The total volume of the bag was 445.36 ml.The reporter stated that approximately 1.6 ml of magnesium was dispensed during preparation based on their calculation of 799.15mg x 1ml/500mg = 1.598 ml.The staff compared the volume and analytes between the values generated during testing to all other bags prepared on the date of the event.They eliminated the possibility of 2 lines/ports being mixed up.Additionally, they did not identify any other orders that matched the calculated volumes aside from one dose that matched the 1.6ml which was for an adult order.The adult bag was 980ml and the bag of the patient involved was 500ml.The reporter has instructed staff to remove the magnesium from the compounder and add it manually.Treatment and patient outcome were not reported.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 and h11.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The machine underwent functional testing and device performed according to product specifications.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was not verified.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): ECM - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24316948
• Report Number: 1416980-2026-00546
• Device Sequence Number: 17561978
• Product Code: NEP
• UDI-Device Identifier: 00085412586557
• UDI-Public: (01)00085412586557
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EXACTA-M
• Device Catalogue Number: EXACTAM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: MAGNESIUM; TOTAL PARENTERAL NUTRITION BAG
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown