Infusomat® 363420Recalls & reported problems
B. Braun Medical Inc. · 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE® · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This B. Braun Infusomat Space IV administration set is used to deliver IV drugs and fluids. Most of the 29 reports describe fluid or blood leaking from the tubing and false air-in-line alarms that stop the pump and interrupt treatment, sometimes forcing nurses to switch lines or fall back on gravity infusion, with no deaths or injuries reported. Three recalls are open, including one started in October 2025 about medication backflow between IV containers and an inability to prime.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04046964294594), received between Mar 2, 2017 and May 16, 2025 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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-2387-2024 · 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
- Fluid/Blood Leak16
- Air/Gas in Device12
- Device Alarm System1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient8
- Chemical Exposure4
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "ALARM. UNABLE TO RUN IVIG ON PUMP, AIR IN LINE ALARM. HAD TO RUN TREATMENT BY GRAVITY. TREATMENT TOOK LONGER TO RUN THAN EXPECTED. CHANGED TUBING WITH EACH BOTTLE CHANGE, NO CHANGE WITH ALARMS." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035007 ↗MalfunctionMar 26, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: COMPLAINT DESCRIPTION: IV PUMP CONTINUOUSLY BEEPING. AIR BUBBLES" BUT NO AIR BUBBLES." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21697688 ↗MalfunctionJan 7, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): WHILE INFUSING CABAZITAXEL, AIR BUBBLES FORMED WITHIN LINE WITH > 150 MLS IN BAG, ALL ABLE TROUBLE SHOOTING RECOMMENDATIONS FOLLOWED. EVENTUALLY AIR ACCUMULATION IN LINE ALARM.ABLE TO INFUSE BY FLICKING AND RESTARTING PUMP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21091189 ↗MalfunctionJan 6, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): AIR IN LINE; PACLITAXEL. SEVERAL TIMES VERY INCONVENIENT. TOOK LONGER TO INFUSE MEDICATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21084986 ↗MalfunctionJan 6, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "CETUXIMAB WHICH IS SUPPLIED IN A PVC-FREE BAXTER BAG BEGAN BEEPING AIR IMMEDIATELY. TRIED CLEANING TUBING, CHANGING PUMP AND FLICKING AIR. UNABLE TO SWITCH LINE DUE TO RISK OF LOSING SOME OF THE MEDICATION. CONSISTENTLY BEEPED AIR IN LINE, WITH SMALL AIR BUBBLES VISIBLE. COULD FLICK THE AIR UP THE LINE A BIT AND INFUSE FOR A COUPLE OF MINUTES BEFORE NEEDING TO RETURN TO THE PUMP TO REPEAT. DRUG EVENTUALLY INFUSED, BUT FAR LONGER THAN EXPECTED DUE TO FREQUENT REQUIRED INTERVENTIONS." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080509 ↗MalfunctionDec 10, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): CONTINUOUS BEEPING ALARM "AIR IN LINE". ATTEMPTED TO TROUBLESHOOT WITH 4 DIFFERENT NURSES FOR 45 MIN. NO SUCCESS. PROBLEM RESOLVED AFTER SWITCHING TO CYTOSET HOWEVER PATIENT MISSED 17 MLS OF DRUG CAUGHT IN PREVIOUS TUBING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892719 ↗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 363420, LOT 0061924849) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PROCEDURE TOOK LONGER TO RUN DUE TO CONTINUOUS AIR.THE DOOR WAS OPENED, THE TUBING WAS REMOVED, INSPECTED, AND TAPPED, TO OBSERVE AND CONFIRM THAT NO AIR WAS PRESENT IN THE LINE, BUT VISIBLE AIR BUBBLES WERE FOUND. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE 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 20845812 ↗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 363420, LOT UNKNOWN) WAS BEING USED TO ADMINISTER PACLITAXEL AT 206 MILLILITERS (ML) PER HOUR ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PUMP SHOWED ACCUMULATED AIR-TRIED TAPPING OUT AIR AND TAPING TUBING UP ON THE PUMP. THE PRIME FUNCTION WAS INITIALLY USED TO REMOVE AIR FROM THE LINE AND THE INFUSION WAS RESTARTED. HOWEVER, AN AIR IN LINE ALARM REOCCURRED. 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 REOCCUR. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE 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 20843805 ↗MalfunctionNov 20, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE INTRAVENOUS (IV) PUMP SET (MATERIAL 363420, LOT 0061868575) WAS BEING USED TO ADMINISTER PACLITAXEL ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE LINE WAS REPEATEDLY ALARMING FOR AIR. PUMP THEN ALARMED THAT "AIR ACCUMULATION MAXIMUM" HAD BEEN REACHED.CHAMPAGNE BUBBLES WERE TAPPED OUT. LINE EVENTUALLY NEEDED TO BE CAVI WIPED AND PLACED BACK IN PUMP. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734738 ↗MalfunctionNov 18, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE INTRAVENOUS (IV) PUMP SET (MATERIAL 363420, LOT 0061924849) WAS BEING USED TO ADMINISTER LEUCOVORIN ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THERE WERE CHAMPAGNE BUBBLES IN THE IV LINE DURING TREATMENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20705493 ↗MalfunctionAug 11, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE) : THE CUSTOMER INFORMED US THAT THEIR ONCOLOGY TEAM HAVE NOTICED LEAKAGE. THE TUBING COMES FROM THE PHARMACY AND IT IS CONNECTED TO A CHEMOTHERAPY SOLUTION (DOCETAXEL-TAXOTERE). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17514527 ↗MalfunctionJun 22, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: DEFECTIVE PRODUCT -IV TUBING FOR TPN - BLOOD BACKED UP INTO TPN LINE, THE AREA BETWEEN THE FILTER TO THE MICOCLAVE CAME APART SLIGHTLY AND ALLOWED AIR IN CAUSED TO BACK UP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17180923 ↗MalfunctionJun 22, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: DEFECTIVE PRODUCT -IV TUBING FOR TPN - BLOOD BACKED UP INTO TPN LINE, THE AREA BETWEEN THE FILTER TO THE MICOCLAVE CAME APART SLIGHTLY AND ALLOWED AIR IN CAUSED TO BACK UP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17180922 ↗MalfunctionNov 3, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DURING ADMINISTRATION OF CHEMOTHERAPY ON A PATIENT, A NURSE NOTICED A LIQUID LEAK ON THE UNDERPAD, COMING FROM THE TUBING FILTER. THE TUBING WAS REMOVED FROM THE PATIENT AND ADDITIONAL TUBING WAS INSTALLED. THE DEFECTIVE TUBING WAS DESTROYED, AS IT CONTAINED A CHEMOTHERAPEUTIC AGENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10781263 ↗MalfunctionApr 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: DURING FLUSH BETWEEN CARBOPLATIN AND ETOPOSIDE ADMINISTRATION, PATIENT AND NURSE NOTICED FLUID BUILDUP ON ARM OF CHAIR AND PATIENT ARM/HAND.
Patient problems: Chemical Exposure
MAUDE report 9935684 ↗MalfunctionApr 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: DRUG: DOCETAXEL 100MG/255ML GIVEN OVER 1 HOUR. PATIENT EXPOSED AS DRIPS FROM FILTER LANDED ON HER LEG.
Patient problems: Chemical Exposure
MAUDE report 9935668 ↗MalfunctionApr 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: DRUG: DOCETAXEL 100MG/255ML GIVEN OVER 1 HOUR. PATIENT EXPOSED AS DRIPS FROM FILTER LANDED ON HER LEG.
Patient problems: Chemical Exposure
MAUDE report 9935666 ↗MalfunctionApr 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: DRUG: CISPLATIN 70MG ADDED TO 500ML NS, GIVEN OVER 1 HOUR, PATIENT AND NURSE NOTICED FLUID BUILDUP ON ARM OF CHAIR AND PATIENT ARM/HAND.
Patient problems: Chemical Exposure
MAUDE report 9935644 ↗MalfunctionFeb 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF TAXOL, THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9695522 ↗MalfunctionFeb 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF TAXOL, THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9695521 ↗MalfunctionFeb 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF TAXOL, THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9695518 ↗MalfunctionFeb 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF TAXOL, THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9695512 ↗MalfunctionFeb 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF TAXOL, THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9694008 ↗MalfunctionFeb 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF TAXOL, THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9694003 ↗MalfunctionFeb 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF TAXOL, THE FILTER LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9694000 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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