APEX™ 601220Recalls & reported problems
B. Braun Medical Inc. · APEX, LOAD CELL MODULE · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964801044), received between Dec 11, 2018 and Jun 24, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (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.
Reports received per month
Most reported problems
Device problems
- Thermal Decomposition of Device4
- Application Program Problem: Dose Calculation Error1
Patient problems
- No Patient Involvement4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: CUSTOMER IS STATING THAT THEY ARE GETTING INGREDIENTS RUNNING DRY BEFORE THE APEX IS LETTING THE USER KNOW THAT THE INGREDIENT SHOULD BE EMPTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22321872 ↗MalfunctionFeb 1, 2019Thermal Decomposition of Device; Thermal Decomposition of Device
AS PER USER FACILITY: CUSTOMER REPORTED THE LOAD CELL CABLE HAS DISCOLORATION ON IT. THE DISCOLORATION LOOK BURNT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8296628 ↗MalfunctionFeb 1, 2019Thermal Decomposition of Device; Thermal Decomposition of Device
AS PER USER FACILITY: CUSTOMER REPORTED THE LOAD CELL CABLE HAS DISCOLORATION ON IT. THE DISCOLORATION LOOK BURNT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8296617 ↗MalfunctionFeb 1, 2019Thermal Decomposition of Device; Thermal Decomposition of Device
AS PER USER FACILITY: CUSTOMER REPORTED THE LOAD CELL CABLE HAS DISCOLORATION ON IT. THE DISCOLORATION LOOK BURNT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8296615 ↗MalfunctionDec 11, 2018Thermal Decomposition of Device; Thermal Decomposition of Device
AS PER USER FACILITY: CUSTOMER REPORTED THAT WHILE TROUBLESHOOTING FAILED LOAD CELL CALIBRATIONS IT WAS DISCOVERED THAT A PORTION OF THE POWER CABLE APPEARED TO BE BLACKENED AND POSSIBLY BURNT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8150123 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.