APEX® 601237Recalls & reported problems
B. Braun Medical Inc. · APEX, SCDM CONTROL MODULE, WIN-10 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046955589524), received between Jun 5, 2024 and Jul 9, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Application Program Problem: Dose Calculation Error2
- Application Program Freezes or Fails to Launch1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025Application Program Problem: Dose Calculation Error; Application Program Freezes or Fails to Launch; Application Program Problem: Dose Calculation Error; Application Program Freezes or Fails to Launch
AS REPORTED BY THE USER FACILITY: HEALTH PROFESSIONAL TEAM NOTICED THAT THERE HAVE BEEN A HANDFUL OF ORDERS BEING PUMPED AT BBMUS # (B)(4) THAT ARE HAVING A DISCREPANCY OF EXACTLY 13MLS FOR LINE 1 (STERILE WATER) OF WHAT IS ORDERED AND WHAT IS PUMPED. HEALTH PROFESSIONAL WAS INFORMED THAT AN ERROR OCCURRED ON THAT PUMP A LITTLE AFTER LUNCH (1PM) THAT CAUSED THEM TO RESTART THE PUMP. THE TIME STAMPS OF SOME IMPACTED BAGS ARE 2:34PM AND 3:08PM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461190 ↗MalfunctionJun 5, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT UPON COMPOUNDING IT IS NOTED CERTAIN STATIONS RUNNING DRY AND SHOWING A NEGATIVE VOLUME ON SCREEN. NO NOTIFICATIONS SEEN TO CHANGE A SOLUTION. THIS HAS BEEN AN INTERMITTENT ISSUE INCLUDING THE FOLLOWING OCCURENCES: THIS OCCURS ON STATION 1 WATER WHEN BY ITSELF AND WHEN Y LINKED TO STATION 2. THIS OCCURS ON STATION 22 PLENAMINE WHEN BY ITSELF AND WHEN LINKED TO STATION 23. STATIONS RUN DRY PULLING BUBBLES WITHOUT ANY ALERTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19467398 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.