APEX™ 601223Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964801051), received between Feb 12, 2020 and Sep 21, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Application Program Problem: Dose Calculation Error

  As reported by the user facility: Several source containers running dry during dispense.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840785 ↗
• MalfunctionFeb 10, 2023Failure to Align; Failure to Align

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED AN ISSUE WITH VALVE 3 BEING MISALIGNED DURING STARTUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358354 ↗
• MalfunctionOct 11, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: A PATIENT ORDER WAS COMPOUNDED BUT THE PUMP DID NOT DISPENSE ANY DEXTROSE TO THE FINAL CONTAINER. IT WAS STATED THAT THE PATIENT ORDER WAS COMPLETED SUCCESSFULLY AND DECLARED IN RANGE BY THE SOFTWARE, YET THE COMPOUNDING ACTIVITY REPORT SHOWED ZERO (0) DEXTROSE WAS DISPENSED. THE FINAL CONTAINER WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605310 ↗
• MalfunctionFeb 12, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER HAS RECEIVED COMPLAINTS THAT THEIR TPN BAGS ARE RUNNING OUT BEFORE THEY SHOULD. THIS OCCURRED WITH TWO (2) PATIENTS. THIS REPORT IS FOR PATIENT #2, NEONATE PATIENT. CUSTOMER REPORTED THAT ALL BAGS THAT RAN DRY HAD TOTAL EXPECTED WEIGHT TO TOTAL WEIGHT VARIANCES OF 1% TO 1.5%. SOME OF THE VARIANCES IN TOTAL WEIGHT WERE OVERWEIGHT AND SOME WERE UNDERWEIGHT. THERE WAS NO HARM CAUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699315 ↗
• MalfunctionFeb 12, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER HAS RECEIVED COMPLAINTS THAT THEIR TPN BAGS ARE RUNNING OUT BEFORE THEY SHOULD. THIS OCCURRED WITH TWO (2) PATIENTS. THIS REPORT IS FOR PATIENT #1, ADULT PATIENT. CUSTOMER REPORTED THAT ALL BAGS THAT RAN DRY HAD TOTAL EXPECTED WEIGHT TO TOTAL WEIGHT VARIANCES OF 1% TO 1.5%. SOME OF THE VARIANCES IN TOTAL WEIGHT WERE OVERWEIGHT AND SOME WERE UNDERWEIGHT. THERE WAS NO HARM CAUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699308 ↗