EXACTAMIX EXACTA24-DYRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412609041), received between Aug 29, 2023 and May 6, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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, I

  Patient problems: Hyperglycemia

  MAUDE report 21973690 ↗
• MalfunctionDec 30, 2024Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-BAXTER FILTER SETS WERE BROWNING AT THE FILTER DURING INFUSION WHILE USING AN EXACTAMIX PHARMACY COMPOUNDING DEVICE. THIS ISSUE OCCURRED AFTER ADDING CYSTEINE TO THE PEDIATRIC TOTAL PARENTERAL NUTRITION (TPN) FORMULATIONS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21041617 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT THE DISPLAY CABLE OF AN AUTOMATED COMPOUNDING DEVICE (ACD) WAS FRAYED CAUSING A LINE BREAK ERROR. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641044 ↗