B.BRAUN 2112550Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 04046964656101), received between Jun 28, 2018 and Sep 4, 2026 — classified as 74 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (45 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611614 ↗
• MalfunctionJul 28, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053636 ↗
• MalfunctionJul 28, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053634 ↗
• MalfunctionMay 6, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: THE CUSTOMER REPORTED THAT THEY HAVE A TRANSFER SET WHERE THE FLEX MICRO LINES FOR PORTS 2 AND 3 ARE SWITCHED AND GOING INTO THE EACH OTHER'S MANIFOLD PORTS. MICRO LINES 2 AND 3 GOING INTO WRONG MANIFOLD PORTS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104464 ↗
• MalfunctionMay 6, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: LABELS ON LINES 4 AND 5 REVERSED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25098965 ↗
• MalfunctionApr 29, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: LEADS MISLABELED. UPON INSTALLING TXS ON PUMP MODULE CUSTOMER NOTICED TUBING 4 WAS LABELED AS 5 AND TUBING 5 WAS LABELED AS 4. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028277 ↗
• MalfunctionJan 12, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED FINDING A BLACK SPECK ON LINE FIVE OF AN APEX TRANSFER SET FRESH OUT OF THE PACKAGING. CUSTOMER IS WARY OF USING TRANSFER SET. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035978 ↗
• MalfunctionJan 9, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED DISCOVERING A WHITE RESIDUE OF SOME KIND ON SEVERAL OF THE PORTS COMING OUT OF THE TRANSFER SET MANIFOLD. CUSTOMER STATED THAT THEY DID NOT LIKE THE LOOK OF THE WHITE SUBSTANCE AND WERE RELUCTANT TO USE THE TRANSFER SET. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019828 ↗
• MalfunctionOct 23, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: AFTER UNBOXING, THE FLAGS FOR LINES 22 AND 23 WERE SWITCHED WITH EACH OTHER. THE DEVICE WAS RETURNED TO NORMAL OPERATING STATE BY USING A DIFFERENT TRANSFER SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23371018 ↗
• MalfunctionAug 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: THE CUSTOMER REPORTED THAT THEY HAVE A TRANSFER SET THAT HAS PARTICLES IN THE MAIN MICRO LINE NEAR WHERE IT PASSES THROUGH THE SENSOR CHANNELS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923882 ↗
• MalfunctionAug 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: A BROWN PARTICLE WAS OBSERVED ON THE TIP OF LINE 1 OF THE APEX TRANSFER SET. NO PATIENT INVOLVEMENT. CUSTOMER REPORTING TXS HAS A BROWN PARTICLE ON THE TIP OF LINE 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881562 ↗
• MalfunctionAug 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: UPON INSTALLING TXS ON PUMP THEY NOTICED A HAIR LOCATED IN THE TUBING, LINE 18.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739782 ↗
• MalfunctionAug 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: "WHEN SETTING UP AN APEX PUMP WE NOTICED SOMETHING STUCK IN THE TUBING FOR LINE 14."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738970 ↗
• MalfunctionMay 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: DIRTY PORT ON LINE 13 - OUT OF BOX FAILURE. CUSTOMER RETURNED TO OPERATING STATE BY USING A DIFFERENT TRANSFER SET. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081042 ↗
• MalfunctionMar 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A DARK SPEC OR INCLUSION WAS NOTED ON THE TXS, LINE 17. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605041 ↗
• MalfunctionMar 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: VISIBLE SPECK IN SET TUBING USER REPORTED THAT THEY OPENED A TRANSFER SET THIS MORNING AND FOUND A VISIBLE SPECK ON THE INSIDE OF THE TUBING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21555122 ↗
• MalfunctionDec 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: END USER REPORTING A BLACK SPEC ON ONE OF THE TRANSFER SET VALVES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901379 ↗
• MalfunctionOct 11, 2024Labelling, Instructions for Use or Training Problem; Contamination /Decontamination Problem; Labelling, Instructions for Use or Training Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY, THE RPH DURING PRIMING, AND PRIOR TO USE FOR ANY COMPOUNDING. THE RPH REMOVED THE LABELS AND SWITCHED THE #7 LABEL TO THE APPROPRIATE LINE, AND RETAINED THE #6 LINE (NOT IN USE). THEN DURING THE PUMPING OF THE FIRST BAG OF THE DAY, THERE WAS PRECIPITATION NOTED IN THE TUBE SET NEAR WHERE THE TUBE CONNECTS TO THE FINAL CONTAINER. THIS WAS SEEN WHEN THE CALCIUM WAS PUMPING, AND IT WAS THEN SEEN FLOWING INTO THE FINAL CONTAINER DURING WATER FLUSH. THE WHOLE SET WAS THEN REMOVED AND BAG WASTED. AFTER SETTING UP A NEW TRANSFER SET THE SAME ORDER WAS PUMPED WITHOUT INCIDENT. WE AREN'T REALLY SURE WHAT HAPPENED. THEY LOOKED AT THE CALCIUM SOURCE CONTAINER AND DIDN'T SEE ANY PRECIPITATION. THERE IS THE EXTRA UI FLUSH SET UP AFTER PHOS INGREDIENTS. INLET LABELS 6 AND 7 WERE TRANSPOSED ON APEX TRANSFER SET LOT 0061934103. THIS WAS CAUGHT TODAY BY THE RPH DURING PRIMING, AND PRIOR TO USE FOR ANY COMPOUNDING. THE RPH REMOVED THE LABELS AND SWITCHED THE #7 LABEL TO THE APPROPRIATE LINE, AND RETAINED THE #6 LINE (NOT IN USE). THEN DURING THE PUMPING OF THE FIRST BAG OF THE DAY, THERE WAS PRECIPITATION NOTED IN THE TUBE SET NEAR WHERE THE TUBE CONNECTS TO THE FINAL C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428992 ↗
• MalfunctionOct 10, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED, (B)(6) CALLED TO REPORT A DEFECTIVE TRANSFER SET THAT THEY OBSERVED FLUID BACKING INTO THE UNUSED LINES ON THE TRANSFER SET DURING PRODUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417014 ↗
• MalfunctionJun 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION TRANSFER SET (B)(4). - HAIR INSIDE THE TUBING - OUT OF BOX FAILURE - DISPOSABLE RETURN ISSUE(S) REPORTED: · THE CUSTOMER REPORTED THAT A TRANSFER SET HAD A HAIR INSIDE IT WHENEVER THEY REMOVED IT FROM THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519337 ↗
• MalfunctionApr 23, 2024Failure to Align; Failure to Align

  AS REPORTED BY THE USER FACILITY: EVENT 2: VALVES WERE NOT STRAIGHT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162832 ↗
• MalfunctionApr 23, 2024Failure to Align; Failure to Align

  AS REPORTED BY THE USER FACILITY: EVENT 1: VALVES WERE NOT STRAIGHT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162831 ↗
• MalfunctionApr 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLACK DOTS IN MACRO LINE 5 NEAR MANIFOLD NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086712 ↗
• MalfunctionJan 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION HAIR FOUND IN TRANSFER SET. DURING OUR SETUP FOR COMPOUNDING A HAIR WAS FOUND IN THE STERILE 26-LEAD TRANSFER SET. LOT # 0061885737 EXP: 04/30/2025. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569604 ↗
• MalfunctionNov 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: IT WAS REPORTED THAT AFTER INITIAL SETUP THE APEX TRANSFER SET HAD A BLACK PARTICULATE IN PORT 2 MACRO OF THE TUBING JUST BEFORE THE MANIFOLD. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147501 ↗