APEX™ 601224Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964801068), received between Apr 12, 2019 and Sep 3, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2019Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS PER USER FACILITY: CUSTOMER REPORTED THEY HAD ADDED THE NEW SMOFLIPID TO THEIR SCDM DATABASE EARLIER IN THE DAY BUT THE COMPOUNDER WAS NOT PUMPING THE CORRECT AMOUNT FOR THE PATIENT ORDER. THE COMPOUNDER WAS PUMPING WATER INSTEAD OF THE SMOFLIPID SOLUTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8955177 ↗
• MalfunctionApr 12, 2019Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS PER USER FACILITY: CUSTOMER REPORTED AN ENCOUNTER AN ISSUE WHERE WHEN THE UNIVERSAL INGREDIENT (UI) IS SELECTED TO BE SOMETHING OTHER THAN WATER AND THE CONTAINER IS CHANGED DURING A MANIFOLD FLUSH THE SOFTWARE CHANGES THE UI TO LINE 1 WATER. IN THIS CASE THE UI WAS LINE 3 TROPHAMINE AND IT CHANGED TO LINE 1 WATER WHEN THE TROPHAMINE CONTAINER WAS CHANGED. THE UI WAS CHANGED BACK TO TROPHAMINE BY THE OPERATOR AND COMPOUNDING WAS ABLE TO CONTINUE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8508402 ↗