APEX™ AX1000Recalls & reported problems
B. Braun Medical Inc. · APEX® Compounding System · Class 2
Quick summary
The APEX AX1000 is a B. Braun automated compounding system that prepares personalized IV nutrition and drug bags in hospitals and pharmacies. Across 47 adverse event reports since 2018, users mostly describe wrong dose calculations, tubing or container alignment failures, and fluid flowing into the wrong line or running out early; no deaths and no injuries were reported. There are no recalls naming this device, and no reports were filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04046955048502), received between Jan 3, 2018 and Jul 12, 2023 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (18 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
Device problems
- Application Program Problem: Dose Calculation Error18
- Failure to Align17
- Improper Flow or Infusion7
- Contamination of Device Ingredient or Reagent3
- Device Alarm System3
- Contamination /Decontamination Problem2
- Application Program Problem: Parameter Calculation Error1
- Contamination1
Patient problems
- No Patient Involvement27
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient4
- Electrolyte Imbalance1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2023Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED 1 SPECIFIC ORDER WAS COMPOUNDED 7 TIMES, 6 WERE SUCCESSFUL, 1 WAS SCRAPPED DUE TO FINAL CONTAINER BEING CLOUDY. NO LIPIDS WERE IN THIS ORDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17308465 ↗MalfunctionFeb 10, 2023Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED A TPN COMPOUNDED AT THEIR FACILITY IS SUSPECTED TO HAVE HAD A POTENTIAL COMPOUNDING ERROR DURING THE APEX PROCESS PROCEDURE.
Patient problems: Electrolyte Imbalance
MAUDE report 16358352 ↗MalfunctionDec 14, 2022Device Alarm System; Device Difficult to Program or Calibrate; Failure to Align; Device Alarm System; Device Difficult to Program or Calibrate; Failure to Align
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THE MANIFOLD WAS OBSERVED RAISING OFF THE PUMP AND FAILED THE VALVE CHECK EXERCISE AND LEAK CHECK. A NEW TRANSFER SET FROM A DIFFERENT LOT WAS INSTALLED AND THE LEAK CHECK PASSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15979317 ↗MalfunctionAug 18, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
AS REPORTED BY THE USER FACILITY: CUSTOMER CALLED TO REPORT THAT SHE SET UP HER TRANSFER SET THIS MORNING, AND SHE NOTICED THAT WHENEVER SHE PRIMED LINE 9, FLUID WAS ENTERING LINE 8 AS WELL DURING PRIMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15255047 ↗MalfunctionMay 10, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: PRECIPITATION NOTICED IN FINAL CONTAINER, OCCURRED (B)(6) 2022. POTASSIUM PHOSPHATE WAS ON LINE 20 / CALCIUM WAS ON LINE 8.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14345640 ↗MalfunctionFeb 22, 2022Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: IT WAS OBSERVED THE TRANSFER SET HAD WHAT APPEARS TO BE RESIDUE IN IT FROM THE LIPIDS USED THAT DAY IN PRODUCTION. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13578760 ↗MalfunctionOct 12, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: INFUSION BAGS ARE RUNNING DRY EARLY WHEN ADMINISTERED TO PATIENTS. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12613800 ↗MalfunctionOct 11, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: INFUSION BAGS ARE RUNNING DRY EARLY WHEN ADMINISTERED TO PATIENTS. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12606671 ↗MalfunctionMar 8, 2021Device Alarm System; Application Program Problem: Dose Calculation Error; Device Alarm System; Application Program Problem: Dose Calculation Error
AS PER REPORTED BY THE USER FACILITY: WHILE COMPOUNDING ORDERS IT WAS OBSERVED THAT NO SOLUTION WAS BEING DRAWN/PUMPED FROM TRALEMENT (IN A SYRINGE ON STATION 13) INTO THE FINAL CONTAINERS. STATION 13 DISPENSED A TOTAL OF 17 TIMES PRIOR TO THE USER NOTICING THAT SOLUTION WAS NOT FLOWING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11436767 ↗MalfunctionFeb 25, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS PER REPORTED BY THE USER FACILITY: OCCLUSIONS WERE RECEIVED ON LINE 9 (MAGNESIUM). DURING TROUBLESHOOTING PARTICULATES WERE OBSERVED IN THE TUBING LEADING TO THE FINAL CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11379786 ↗MalfunctionDec 22, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS PER REPORTED BY THE USER FACILITY: THE SOLUTION ON LINE 20 CHANGED FROM SODIUM PHOSPHATE TO POTASSIUM PHOSPHATE IN THE APEX SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11054671 ↗MalfunctionNov 4, 2020Application Program Problem: Dose Calculation Error; Use of Device Problem; Application Program Problem: Dose Calculation Error; Use of Device Problem
AS PER REPORTED BY THE USER FACILITY: A LARGER VOLUME OF THE CONCENTRATED SODIUM CHLORIDE WAS NEEDED THAN NORMAL. A VACUUM WAS CREATED WHILE USING THE MINISPIKE ON A GLASS VIAL. THE USER CHANGED TO A VENTED SPIKE, BUT DID NOT CHANGE THE SETTING ON THE COMPOUNDER SOFTWARE. ALL OF THE BAGS WERE LOCATED AND SCRAPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10786103 ↗MalfunctionSep 17, 2020Device Alarm System; Application Program Problem: Dose Calculation Error; Device Alarm System; Application Program Problem: Dose Calculation Error
AS PER REPORTED BY THE USER FACILITY: IT WAS NOTICED ABOUT HALFWAY THROUGH THE PRODUCTION DAY THAT MICRO LINE 12 (LEVOCARNITINE) WAS NOT DISPENSING FLUID. THREE (3) BAGS WERE SCRAPPED THAT WERE POSSIBLY PUMP WITH AN INCOMPLETE FINAL CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10545798 ↗MalfunctionSep 3, 2020Failure to Align; Contamination of Device Ingredient or Reagent; Failure to Align; Contamination of Device Ingredient or Reagent
AS PER USER FACILITY: IT WAS STATED FLUID FROM EITHER PORT 25 (SMOF LIPID) OR PORT 26 (NUTRILIPID) IS FLOWING BACKWARDS INTO THE TRANSFER SET MANIFOLD. IT IS UNKNOWN WHICH INGREDIENT IS FLOWING BACKWARDS. THE TRANSFER SET WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10489274 ↗MalfunctionAug 25, 2020Failure to Align; Contamination of Device Ingredient or Reagent; Failure to Align; Contamination of Device Ingredient or Reagent
AS PER USER FACILITY: IT WAS STATED THAT THE PUMP RAN FINE FOR THE MAJORITY OF THE DAY. DURING TROUBLESHOOTING FOR OCCLUSIONS THE LINES WERE REPRIMED AND A MANIFOLD FLUSH WAS DONE. AFTER THE STERILE WATER ON LINE 1 WAS FINISHED PULLING FOR THE FLUSH, IT WAS OBSERVED THAT LIPIDS WERE BEING PUSHED THROUGH THE TRANSFER SET TUBING. THE LIPIDS BEING USED WERE SMOF LIPID 20% ON LINE 25 (MACRO) AND NUTRILIPID ON LINE 26 (MACRO). WHEN THE TRANSFER SET WAS REMOVED IT WAS NOTICED THAT THE VALVE ON THE TRANSFER SET MANIFOLD ON LINE 25 (SMOF LIPID 20%) WAS STUCK IN AN OPEN POSITION. THERE WERE VISIBLE MARKINGS ON THE VALVE THAT WERE INDICATIVE OF AN ATTEMPT TO CLOSE BUT FAILED TO DO SO. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10447443 ↗MalfunctionJul 1, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THEY PERFORMED THE APEX DATA UPDATE PART 1 OF THE NON-DEFAULT DATA WHICH CHANGED SOME OF THE FLOW FACTORS. THE TECHNICIANS REPORTED CERTAIN SOLUTIONS ARE RUNNING DRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10219430 ↗MalfunctionJul 1, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THEY PERFORMED THE APEX DATA UPDATE PART 1 OF THE NON-DEFAULT DATA WHICH CHANGED SOME OF THE FLOW FACTORS. THE TECHNICIANS REPORTED CERTAIN SOLUTIONS ARE RUNNING DRY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10219409 ↗MalfunctionMar 20, 2020Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED A BAG WAS COMPOUNDED AND THE COMPOUNDER ALLOWED A MICRO BUBBLE OF 8.71ML WITHOUT REQUIRING INTERVENTION FROM A PHARMACIST. THE ORDER WAS DISCARDED AND REMADE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9859390 ↗MalfunctionFeb 21, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: EVENT 3. CUSTOMER REPORTED THREE (3) PATIENTS HAVE EXPERIENCED FINAL COMPOUNDED BAGS RUNNING DRY PRIOR TO THE END OF THE INFUSION TIME. THIS REPORT IS FOR PATIENT #3. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9738885 ↗MalfunctionFeb 21, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTED THREE (3) PATIENTS HAVE EXPERIENCED FINAL COMPOUNDED BAGS RUNNING DRY PRIOR TO THE END OF THE INFUSION TIME. THIS REPORT IS FOR PATIENT #1. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9738882 ↗MalfunctionFeb 21, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS REPORTED BY THE USER FACILITY: EVENT 2. CUSTOMER REPORTED THREE (3) PATIENTS HAVE EXPERIENCED FINAL COMPOUNDED BAGS RUNNING DRY PRIOR TO THE END OF THE INFUSION TIME. THIS REPORT IS FOR PATIENT #2. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9738881 ↗MalfunctionFeb 12, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS PER B. BRAUN IMPLEMENTATION SPECIALIST: CUSTOMER REPORTED WHILE COMPOUNDING AN ORDER THE PHARMACIST NOTICED MVI DISPENSING OUT OF SEQUENCE. MVI WAS LOCATED ON PORT 19 AND SHOULD HAVE DISPENSED FOURTH IN THE SEQUENCE. THE PUMP WAS IMMEDIATELY SHUT DOWN AND THE BAG WAS SCRAPPED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Patient Involvement
MAUDE report 9699250 ↗MalfunctionJan 7, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS PER B. BRAUN IMPLEMENTATION SPECIALIST: CUSTOMER WAS EXPERIENCING ISSUES WITH THEIR SMOFLIPID SOURCE CONTAINERS RUNNING DRY, INDICATING OVERDELIVERY. THERE WAS A PEDIATRIC PATIENT ON A 3-IN-1 TPM THAT INCLUDED SMOF, WHOSE TPN WERE AT +4.9% OVERWEIGHT. THE CUSTOMER HAS THEIR ACCEPTABLE VARIANCE SET TO +/- 5%. THEY OPTED TO SEND THE BAG OUT TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9558113 ↗MalfunctionNov 5, 2019Contamination; Contamination
AS PER USER FACILITY: BUBBLES WERE NOTICED ON LINE 21. DURING RE-PRIMING OF THE LINE IT WAS OBSERVED THAT THE MANIFOLD WAS SUCKING FLUID (MVI) FROM THE MANIFOLD'S COMMON FLUID PATH UP THROUGH THE SOURCE TUBING TOWARDS THE SOURCE SOLUTION ON PORT 21. THE PUMP WAS IMMEDIATELY STOPPED AND THE BAG WAS SCRAPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9279186 ↗MalfunctionSep 3, 2019Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
AS PER USER FACILITY: CUSTOMER REPORTED ISSUES WITH INCORRECT ORDER VOLUMES ON THE COMPOUNDING ACTIVITY REPORT FROM ONE OF THE ORDERS COMPOUNDED. THE ORDER VOLUME, DELIVERED VOLUME, EXPECTED WEIGHT AND TOTAL DELIVERED VOLUME OF INDIVIDUAL INGREDIENTS ARE INCORRECT. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8955182 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.