Infusomat® 363419Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 04046964294570), received between Nov 18, 2016 and Sep 25, 2026 — classified as 1 injury, 108 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (36 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Free or Unrestricted Flow

  As reported by the user facility:Details of complaint (Reported Issue): "Although the wheel of the 0.9% NaCl tubing was completely closed, the blood flowed back up to the 0.9% NaCl sac. The patient received approximately 50 mL of 0.9% NaCl. It appears that the wheel does not allow complete occlusion of the tubing."No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896572 ↗
• MalfunctionJun 8, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "PIERCED AND CRUSHED TUBING RESULTING IN SOLUTE DRIPPING DURING PURGING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435217 ↗
• MalfunctionApr 29, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AIR IN BLOOD TUBING. PRIMED ON PUMP USING PROPER TECHNIQUE (INVERTING BLOOD FILTER). AIR ALARMS EVERY 1-2 MINUTES EVEN WITH TAKING TUBING OUT AND FLICKING BUBBLES THROUGH AND COMPLETING ADDITIONAL PRIMES OF 5-10ML. RESULTED IN TRANSFUSION DURATION INCREASING AS PUMP STOPS WITH EVERY AIR ALARM. MICRO BUBBLES KEPT FORMING FROM THE PUMP DOWN TO THE END OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028426 ↗
• MalfunctionApr 20, 2026Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY: ED STAFF WERE ATTEMPTING TO TRANSFUSE BLOOD PRODUCTS BUT WERE UNABLE TO GET THE ROLLER CLAMP TO WORK ENOUGH TO STOP THE BLOOD FROM BACKFLOWING INTO THE NSS. HEMOSTATS WERE USED ON THE NSS TUBING IN ORDER TO GET BLOOD INFUSED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924614 ↗
• MalfunctionMar 26, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: WHILE INFUSING BLOOD, PRODUCT LEAKED AT THE CIRCULAR PIECE JUST ABOVE THE LAST PORT OF THE LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702535 ↗
• MalfunctionMar 18, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: LEAKAGE AT Y-SITE WHEN TUBING WAS DISCONNECTED FROM THE LAD CLOSEST TO THE PATIENT. LEAKAGE WAS AT THE LAD. ONCE INFUSION WAS COMPLETE, RN DISCONNECTED TUBING FROM Y-SITE, AND THEY SAW FLUID AT THE TOP OF THE LAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625923 ↗
• MalfunctionJun 23, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: TUBING BROKE LEAKING DETAILED INQUIRY DESCRIPTION: TUBING BROKE AND PORTION THAT GOES INSIDE THE PUMP LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306890 ↗
• MalfunctionApr 2, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "BEEPING AIR IN LINE MULTIPLE TIMES DURING BLOOD TRANSFUSION. UNABLE TO CLEAR ALARM. BLOOD THEN RUNNING BY GRAVITY PUTTING PTS AT RISK. TRIED ALL WORK-AROUNDS FROM B BRAUN. RESULTED IN POTENTIAL RISK TO PATIENT AND DECREASED PATIENT EXPERIENCE AS ONLY WAY TO CONTINUE TRANSFUSION IS BY GRAVITY." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755852 ↗
• MalfunctionFeb 13, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "BLOOD TRANSFUSION SET RIPPED FROM Y-SITE PROXIMAL TO INJECTION PORT DURING BLOOD TRANSFUSION. ABOUT 20% OF BLOOD PRODUCT WASTED." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378190 ↗
• MalfunctionJan 23, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE. MULTIPLE ATTEMPTS TO RESOLVE. CHAMPAGNE BUBBLES HAD TO CHANGE IV LINES MID TRANSFUSION." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216681 ↗
• MalfunctionJan 7, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): 2 UNITS PACKED RED BLOOD CELLS SECOND UNIT, CONTINUAL AIR IN LINE FROM CHAMPAGNE BUBBLES DELAYING ADMINISTRATION TIME OF BLOOD PRODUCT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090813 ↗
• MalfunctionDec 10, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): AIR ALARM WITH CHAMPAGNE BUBBLES. LINE PRIMED WITH PUMP. VERY HARD TO SPIKE BAG. HAD TO USE FORCEP AND TOURNIQUET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891219 ↗
• MalfunctionNov 19, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): AIR IN LINE. "SOLVENT DETERGENT PLASMA INFUSING IN Y-TYPE BLOOD SET TUBING. 3RD UNIT OF PLASMA WAS HUNG/INFUSING AND PUMP WAS ALARMING TO AIR IN LINE MULTIPLE TIMES; COULDN'T BE RESOLVED THEREFORE HAD TO CHANGE TUBING AND THEREFORE PT. MISSED OUT ON PLASMA LEFT IN TUBING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722895 ↗
• MalfunctionNov 14, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: "A LOT OF CHAMPAGNE BUBBLES AT PUMP BEFORE AND AFTER. UNABLE TO COMPLETE TRANSFUSION THROUGH THE PUMP. ATTEMPTED PROBLEM SOLVING AS PER RECOMMENDATIONS WITH CAVIWIPE AND FLICKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685868 ↗
• MalfunctionNov 12, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AIR ACCUMULATION DUE TO MICRO BUBBLES, UNABLE TO RECTIFY, WRITER HAD TO REMOVE LINE FROM PUMP AND RUN TRANSFUSION BY GRAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662428 ↗
• MalfunctionOct 29, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WHILE PRIMING WITH BLOOD PRODUCT (PLTS) PUMP INDICATED "DOWSTREAM PRESSURE". UPON ASSESSING TUBING CLAMPS AND CVAD CLAMP, THE BLOOD TUBING RUPTURED AT PROXIMAL Y PORT, WHILE STILL CONNECTED TO PICC. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20555898 ↗
• MalfunctionOct 28, 2024Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: AIR IN LINE. "AFTER SETTING UP AND PRIMING MY LINE THROUGH THE PUMP IT WOULD CONTINUOUSLY ALARM FOR AIR BUBBLE." ADDITIONAL: I WAS REQUIRED TO RUN A BLOOD TRANSFUSION FOR MY PATIENT USING THE B BRAUN INFUSION PUMP. AFTER SETTING UP AND PRIMING MY LINE THROUGH THE PUMP IT WOULD CONTINUOUSLY ALARM FOR AIR BUBBLE YET IN ASSESSING THE LINE NO AIR COULD BE IDENTIFIED. TROUBLESHOOTING THIS ISSUE INVOLVED: REMOVING THE LINE FROM THE PUMP AND RUNNING THE LINE THROUGH MY FINGERS TO WORK OUT ANY KINKS IN THE TUBE. FLICKING THE LINE TO REMOVE ANY MICRO BUBBLES THAT MAY BE DIFFICULT TO SEE. RUNNING MY FINGER ALONG THE LINE INSIDE THE PUMP PRIOR TO CLOSING IT. FILLING THE DRIP CHAMBER WITH MORE OF THE BLOOD, MAKING IT FULLER. CHANGING PUMPS ALL TOGETHER AND REPEATING THE SAME TRICKS, THESE TRICKS WERE ATTEMPTED NUMEROUS TIMES OVER THE COURSE OF HALF AN HOUR BEFORE INVOLVING THE UNIT EDUCATOR. THE UNIT EDUCATOR ATTEMPTED THE SAME TRICKS WITH NO SUCCESS AND THEREFORE THE EDUCATOR FOR ICCS WAS THEN INVOLVED. WIPING THE INNER SENSOR WITH ALCOHOL AND LETTING IT DRY WAS THE ONLY TRICK THAT PROVIDED SOME RESOLUTION TO THE ISSUE, HOWEVER THIS NEEDED TO BE DONE 3 TIMES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543708 ↗
• MalfunctionOct 21, 2024Device Alarm System; Device Alarm System

  AS REPORTED BY USER FACILITY: AIR IN LINE. "AFTER SETTING UP AND PRIMING MY LINE THROUGH THE PUMP IT WOULD CONTINUOUSLY ALARM FOR AIR BUBBLE." I WAS REQUIRED TO RUN A BLOOD TRANSFUSION FOR MY PATIENT USING THE B BRAUN INFUSION PUMP. AFTER SETTING UP AND PRIMING MY LINE THROUGH THE PUMP IT WOULD CONTINUOUSLY ALARM FOR AIR BUBBLE YET IN ASSESSING THE LINE NO AIR COULD BE IDENTIFIED. TROUBLESHOOTING THIS ISSUE INVOLVED: REMOVING THE LINE FROM THE PUMP AND RUNNING THE LINE THROUGH MY FINGERS TO WORK OUT ANY KINKS IN THE TUBE. FLICKING THE LINE TO REMOVE ANY MICRO BUBBLES THAT MAY BE DIFFICULT TO SEE. RUNNING MY FINGER ALONG THE LINE INSIDE THE PUMP PRIOR TO CLOSING IT. FILLING THE DRIP CHAMBER WITH MORE OF THE BLOOD, MAKING IT FULLER. CHANGING PUMPS ALL TOGETHER AND REPEATING THE SAME TRICKS, THESE TRICKS WERE ATTEMPTED NUMEROUS TIMES OVER THE COURSE OF HALF AN HOUR BEFORE INVOLVING THE UNIT EDUCATOR. THE UNIT EDUCATOR ATTEMPTED THE SAME TRICKS WITH NO SUCCESS AND THEREFORE THE EDUCATOR FOR ICCS WAS THEN INVOLVED. WIPING THE INNER SENSOR WITH ALCOHOL AND LETTING IT DRY WAS THE ONLY TRICK THAT PROVIDED SOME RESOLUTION TO THE ISSUE, HOWEVER THIS NEEDED TO BE DONE 3 TIMES THROUGHOUT THE 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493231 ↗
• MalfunctionOct 15, 2024Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIL ALARMS WITH BLOOD TUBING. DETAILED INQUIRY DESCRIPTION: FROM PRODUCT COMPLAINT FORM - PATIENT TO RECEIVE 3 UNITS OF PRBCS OVER 2HRS EACH. INFUSIONS INTERRUPTED MULTIPLE TIMES WITH ALARM AIR IN TUBING. EACH TIME NURSE REMOVED TUBING FROM PUMPS AND NO AIR FOUND IN THE TUBING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456796 ↗
• MalfunctionOct 15, 2024Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIL ALARMS WITH BLOOD TUBING. DETAILED INQUIRY DESCRIPTION: FROM PRODUCT COMPLAINT FORM - PATIENT TO RECEIVE 3 UNITS OF PRBCS OVER 2HRS EACH. INFUSIONS INTERRUPTED MULTIPLE TIMES WITH ALARM AIR IN TUBING. EACH TIME NURSE REMOVED TUBING FROM PUMPS AND NO AIR FOUND IN THE TUBING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454591 ↗
• MalfunctionOct 9, 2024Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIL ALARMS WITH BLOOD TUBING. DETAILED INQUIRY DESCRIPTION: FROM PRODUCT COMPLAINT FORM - PATIENT TO RECEIVE 3 UNITS OF PRBCS OVER 2HRS EACH. INFUSIONS INTERRUPTED MULTIPLE TIMES WITH ALARM AIR IN TUBING. EACH TIME NURSE REMOVED TUBING FROM PUMPS AND NO AIR FOUND IN THE TUBING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406158 ↗
• MalfunctionOct 2, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED, EVENT 1: INFUSING 3 UNITS OF BLOOD TO PATIENT. PUMP KEPT ALARMING "AIR IN LINE" TROUBLESHOOTING DONE (FLUSHING IV SITE), CHECK TUBING IN CHANNEL, TRIED OTHER IV TUBING X 3. KEPT ALARMING, COULD NOT INFUSE BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352007 ↗
• MalfunctionOct 2, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED, EVENT 3: INFUSING 3 UNITS OF BLOOD TO PATIENT. PUMP KEPT ALARMING "AIR IN LINE" TROUBLESHOOTING DONE (FLUSHING IV SITE), CHECK TUBING IN CHANNEL, TRIED OTHER IV TUBING X 3. KEPT ALARMING - COULD NOT INFUSE BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351959 ↗
• MalfunctionOct 2, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED, EVENT 2: INFUSING 3 UNITS OF BLOOD TO PATIENT. PUMP KEPT ALARMING "AIR IN LINE" TROUBLESHOOTING DONE (FLUSHING IV SITE), CHECK TUBING IN CHANNEL, TRIED OTHER IV TUBING X 3. KEPT ALARMING, COULD NOT INFUSE BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351885 ↗
• MalfunctionSep 30, 2024Mechanical Problem; Mechanical Problem

  AS REPORTED BY THE USER FACILITY: BLOOD SET LEAKAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338604 ↗