Infusomat® 363430Recalls & reported problems
B. Braun Medical Inc. · 15 drops/mL, priming volume: 26mL, length: 123in, CARESITE® · Class 2
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This B. Braun Infusomat administration set is IV tubing used with infusion pumps. Its 240 reports mostly describe false air alarms, air in the tubing and leaks, and they fell from 29 in the prior 12 months to 2 in the last 12 months. The reports include no deaths and 4 injuries. All 3 recalls that name this device are open, covering tubing that can trigger false air alarms and medication flowing back from piggyback containers.
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
- 245
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 245 adverse event reports that list this exact device (DI 04046964294679), received between Nov 30, 2016 and Sep 23, 2026 — classified as 4 injuries, 241 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (90 reports).
3 FDA recall records name this device's identifier, 3 still open.
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
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0640-2026 · Root cause: Process control · FDA record ↗
- Jun 17, 2024Open, Classified
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
Z-2392-2024 · Root cause: Process control · FDA record ↗
- Nov 1, 2023Open, Classified
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
Z-0355-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device90
- Device Alarm System90
- Fluid/Blood Leak33
- Leak/Splash21
- Free or Unrestricted Flow8
- Contamination /Decontamination Problem5
- Device Misassembled During Manufacturing /Shipping5
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions204
- No Consequences Or Impact To Patient13
- No Known Impact Or Consequence To Patient12
- Chemical Exposure4
- Hemorrhage/Blood Loss/Bleeding4
- Low Blood Pressure/ Hypotension3
- Insufficient Information2
- Anemia1
Recent adverse event reports
The 25 most recent of 245 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Leak/Splash
As reported by the user facility: We seem to have had some more tubing issues lately with both the primary tubing and the tubing we use for Taxol infusions. Pharmacy has had to reprime a few Taxols during the infusion well after infusion has been running. The issues with the primary tubing seem to be random, different lot numbers and different issues. A lot of high-pressure alarms for no reason or accumulated air alarm, even a leaky y-site here and there.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870312 ↗MalfunctionSep 23, 2026Air/Gas in Device
As reported by the user facility:Air in line during use. No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870264 ↗MalfunctionSep 23, 2026Air/Gas in Device
As reported by the user facility:Air in line during use. No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870193 ↗MalfunctionSep 23, 2026Air/Gas in Device
As reported by the user facility:Air in line during use. No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867040 ↗MalfunctionSep 23, 2026Air/Gas in Device
As reported by the user facility:Air in line during use. No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867036 ↗MalfunctionJun 26, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BLACK MARKINGS WERE NOTED ON THE TUBING DRIP CHAMBER AND ROLLER CLAMP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633650 ↗MalfunctionJun 15, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: PRESSURE-LIMITED CHECK VALVE CAP ON B. BRAUN IV TUBING DETACHED/BLOWN OFF DURING MEDICATION ADMINISTRATION, CAUSING FLUID/MEDICATION LEAKAGE AND POTENTIAL EXPOSURE/SAFETY RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25500746 ↗MalfunctionApr 28, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): WHEN THE AIR IN THE TUBING IS EVACUATED, A HOLE IS PRESENT AND SOLUTE FLOWS OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21920783 ↗MalfunctionMar 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: FOREIGN MATTER IN DRIP CHAMBER OF PUMP SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515861 ↗MalfunctionFeb 13, 2025Free or Unrestricted Flow; Free or Unrestricted Flow
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "INFUSION SET LOADED INTO PUMP AS PRIMARY SET, SET ON PUMP AS SUCH, SECONDARY SET ATTACHED FOR DRUG ADMIN TO PORT BEFORE THE PUMP AND PROGRAMMED TO APPROPRIATE SPECIFIC SETTINGS. IT ALLOWED MEDICATION TO FREELY FLOW THROUGH THE LINE AT A RAPID PACE - WAS NOTED IMMEDIATELY AND PUMP STOPPED. SAME TUBING REMOVED AND REPLACED INTO THE PUMP- STILL OCCURRED. THE SECONDARY SET WAS EXAMINED AND NOT A PROBLEM. INFUSOMAT IV SET REPLACED WITH RECTIFIED THE ISSUE." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378937 ↗MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DESCRIPTION OF DEFECT: PATIENT HAD BLOOD INFUSING ON A PUMP WITH BLOOD TUBING AS SECONDARY, THIS SET ABOVE WAS PRIMARY WITH NSS ATTACHED. NURSE ENTERED ROOM TO ASSIST PATIENT AND NOTED THAT THE PATIENT'S SHEETS WERE WET WITH SALINE WHICH WAS BLOOD TINGED. PATIENT'S BLOOD HAD FINISHED NOT LONG PRIOR AND THE NSS WAS FLUSHING THE LINE AS INDICATED. PATIENT HAD RECEIVED ALL OF BLOOD INFUSION AND NEARLY ALL OF THE REMAINING BLOOD FROM THE TUBING AS WELL. THE TUBING BROKE/SNAPPED AT A PLASTIC CONNECTION ON THE LINE CAUSING THE LEAK OF IV FLUIDS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21344393 ↗MalfunctionJan 23, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE" ALARM. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216564 ↗MalfunctionJan 23, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILS OF COMPLAINT (REPORTED ISSUE): "IV BUBBLES ALARM USED 2 IV INFUSE SET." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216478 ↗MalfunctionJan 23, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILS OF COMPLAINT (REPORTED ISSUE): "IV BUBBLES ALARM USED 2 IV INFUSE SET." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216477 ↗MalfunctionJan 22, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE" ALARM." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21206858 ↗MalfunctionJan 22, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE. BUBBLES NEED TO USE 2 INFUSIONS SET FOR A ONE-TIME DOSE. WASTED 2 IV LINES." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21206820 ↗MalfunctionJan 22, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE. BUBBLES NEED TO USE 2 INFUSIONS SET FOR A ONE-TIME DOSE. WASTED 2 IV LINES." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21206819 ↗MalfunctionJan 21, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AMIODARONE - AIR BUBBLE ALARM TRIED TROUBLE SHOOTING BUT CONTINUED TO ALARM AFTER EACH INTERVENTION." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196842 ↗MalfunctionDec 13, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 363904, LOT 0061940652) WAS BEING USED TO ADMINISTER OBINUTUZUMAB ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, AIR BUBBLE ALARM AND ACCUMULATED AIR ALARMS WHILE DRUG WAS ABOUT HALF WAY DONE.NO BUBBLES WERE VISIBLE, SO THE TUBING WAS RELOADED, AND THE INFUSION WAS RESTARTED. THE ALARM REOCCURRED. THE PUMP WAS CHANGED. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924172 ↗MalfunctionDec 13, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 363430, LOT 0061938519) WAS BEING USED TO ADMINISTER TRASTUZUMAB EMTANSINE (T-DM1) ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE TUBING WAS PROPERLY LOADED. THE PRIME FUNCTION WAS INITIALLY USED TO REMOVE AIR FROM THE LINE AND THE INFUSION WAS RESTARTED. AT THIS TIME, THE DOOR WAS OPENED, THE TUBING WAS REMOVED, INSPECTED, AND TAPPED, TO OBSERVE AND CONFIRM THAT NO AIR WAS PRESENT IN THE LINES. NO BUBBLES WERE VISIBLE, SO THE TUBING WAS RELOADED, AND THE INFUSION WAS RESTARTED. THE ALARM REOCCURRED PROMPTING THE USE OF A NEW PUMP. THE COMPLAINT DEVICE IS NOT AVAILABLE TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20923957 ↗MalfunctionDec 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 363430, LOT 0061951626) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, NURSE OPENED PACKAGE AND NOTICED A FUZZY/MOULDY DISTAL TIP. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901954 ↗MalfunctionDec 10, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): NEAR END OF BAG IV PUMP INDICATED AIR IN LINE MANY TIMES (CHAMPAGNE BUBBLES). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892782 ↗MalfunctionDec 4, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 363430, LOT 0061938519) WAS BEING USED TO ADMINISTER RITUXIMAB ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE TUBING WAS PROPERLY LOADED. AT THIS TIME, THE DOOR WAS OPENED, THE TUBING WAS REMOVED, INSPECTED, AND TAPPED, TO OBSERVE AND CONFIRM THAT NO AIR WAS PRESENT IN THE LINES. NO BUBBLES WERE VISIBLE, SO THE TUBING WAS RELOADED, AND THE INFUSION WAS RESTARTED. THE ALARM REOCCURRED PROMPTING THE USE OF A NEW PUMP. THE COMPLAINT DEVICE IS NOT AVAILABLE TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20845864 ↗MalfunctionNov 18, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): AIR IN LINE ALARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20705554 ↗MalfunctionNov 15, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED, TO B. BRAUN MEDICAL INC.. THAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 363430, LOT#: 0061932555) WAS BEING USED ON OCTOBER 21, 2024. ACCORDING TO THE COMPLAINANT, THE PRIME FUNCTION WAS INITIALLY USED TO REMOVE AIR FROM THE LINE AND THE INFUSION WAS RESTARTED. HOWEVER, AN AIR IN LINE ALARM REOCCURRED. THE PRIME FUNCTION WAS USED ONCE AGAIN TO SUCCESSFULLY PRIME THE LINE, BUT THE AIR-IN-LINE ALARM CONTINUED TO OCCUR. AT THIS TIME, THE DOOR WAS OPENED, THE TUBING WAS REMOVED, INSPECTED, AND TAPPED. TO OBSERVE AND CONFIRM, THAT NO AIR WAS PRESENT IN THE LINES. NO BUBBLES WERE VISIBLE, SO THE TUBING WAS RELOADED AND THE INFUSION WAS RESTARTED. THE ALARM REOCCURRED. PROMPTING THE USE OF A NEW PUMP. REPORTEDLY, THE CHEMOTHERAPY HAD TO EVENTUALLY BE RUN VIA GRAVITY. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED, AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20700941 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.