Infusomat® 480264Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04046955778744), received between Feb 24, 2024 and Sep 15, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (31 reports).

1 FDA recall record name this device's identifier, 1 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Leak/Splash

  As reported by the user facility:The customer has experienced the vent caps from the drip chamber falling off while the nurse was attempting to vent the tubing. This resulted in chemotherapy spilling from the tubing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775190 ↗
• MalfunctionMay 6, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: RN HAPPENED TO NOTICE A SIGNIFICANT AMOUNT OF AIR IN TUBING RIGHT AFTER PUMP AND RIGHT BEFORE CONNECTION TO CAP. THIS OCCURRED APPROXIMATELY 6 HOURS AFTER LINE CHANGE. THIS RN PERSONALLY CHANGED THIS LINE SO CAN ATTEST THAT THERE WAS NO AIR IN THE LINE AT THE TIME OF THE LINE CHANGED AND THAT THE MED WAS PRIMED ON THE PUMP. NO PUMP ALARM FOR AIR IN TUBING AT ANY POINT IN TIME. RN SWITCHED TUBING AND PUMP AND PATIENT WAS CLINICALLY UNCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104765 ↗
• MalfunctionMar 19, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: "SET TUBING KEPT GETTING AIR BUBBLE ALARM. TRIED TROUBLESHOOTING BY FLICKING BUBBLES OUT OF TUBING. A DIFFERENT PUMP WAS USED AND STILL HAD AIR BUBBLE ALARM. TUBING MAY HAVE BEEN THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637682 ↗
• MalfunctionMar 11, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: RN HAPPENED TO NOTICE A SIGNIFICANT AMOUNT OF AIR IN TUBING RIGHT AFTER PUMP AND RIGHT BEFORE CONNECTION TO CAP. THIS OCCURRED APPROXIMATELY 6 HOURS AFTER LINE CHANGE. THIS RN PERSONALLY CHANGED THIS LINE SO CAN ATTEST THAT THERE WAS NO AIR IN THE LINE AT THE TIME OF THE LINE CHANGED AND THAT THE MED WAS PRIMED ON THE PUMP. NO PUMP ALARM FOR AIR IN TUBING AT ANY POINT IN TIME. RN SWITCHED TUBING AND PUMP AND PATIENT WAS CLINICALLY UNCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570534 ↗
• MalfunctionAug 27, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: AIR IN LINE ALARMED WITH NO VISIBLE BUBBLES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906060 ↗
• MalfunctionNov 12, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED TO B. BRAUN MEDICAL INC. HAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 480264, LOT 0061939341). ACCORDING TO THE COMPLAINANT, MEDICATION WAS NOT COMPLETE, APPROXIMATELY 30-40ML LEFT IN BAG, BUT AIR WAS DRAWN INTO THE LINE. THE VENT ON THE SIDE OF THE CHAMBER WAS NOTED TO BE OPEN, THOUGH THIS WAS NOT NOTED AT THE BEGINNING OF THE INFUSION AND NOT KNOWINGLY OPENED BY INFUSION RN. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662223 ↗
• MalfunctionNov 8, 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 480264, LOT UNKNOWN) SUCKED AIR INTO THE PUMP. ACCORDING TO THE COMPLAINANT, IV SET SUCKED AIR INTO THE PUMP AND DRIP CHAMBER EMPTY WHEN THERE WAS STILL FLUID LEFT IN THE BAG. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636748 ↗
• MalfunctionNov 7, 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 480264, LOT UNKNOWN) RAND DRY AND DRIP CHAMBER WHEN THERE WAS STILL MEDS IN THE BAG. ACCORDING TO THE COMPLAINANT, THE PUMP SET RAN DRY AND THE NURSE HAD TO DRAW OUT THE MED LEFT IN THE BAG AND DELIVER VIA SYRINGE FROM INCOMPLETE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636666 ↗
• MalfunctionJun 5, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION BROKEN LINE LOADING GUIDE ON SHORT SET DETAILED INQUIRY DESCRIPTION CALLED TO PATIENT ROOM BY MICHELLE FOR AIR BUBBLE ALARM WITH ARSENIC INFUSION. RN STATED THAT PUMP ALARMED "ALMOST IMMEDIATELY" AFTER START. SHE REMOVED AND RELOADED TUBING SEVERAL TIMES PRIOR TO MY ARRIVAL IN ROOM. UPON SWITCHING PUMPS, NOTICED THAT LINE LOADING GUIDE BROKEN. RN DID NOT RECALL NOTICING THAT OR WHEN IT HAPPENED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472102 ↗
• MalfunctionJun 4, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION PERSISTENT AIL ALARM DESPITE NO VISIBLE AIR. DETAILED INQUIRY DESCRIPTION KEYTRUDA INFUSION OF 58 MLS (PRIMED BY PHARMACY WITH MICRON FILTER IN PLACE PRIOR TO ARRIVAL OF MED ON UNIT). ASV PUT ON END OF SHORT SET TUBING BY RN PRIOR TO INFUSION START WHICH SHE THEN CHANGED TO CLOSER TO PATIENT. VERY SHORTLY AFTER INFUSION STARTED, PUMP ALARMED AIR BUBBLE. NO VISIBLE AIR BUBBLE SEEN WHEN TUBING REMOVED FROM PUMP, ONLY A FEW MICRO BUBBLES VISUALIZED. WHICH PASSED WITH FLICKING OF TUBING. ALL TIPS AND TRICKS UNSUCCESSFUL. THIS OCCURRED ON 4 SEPARATE PUMPS WITH MULTIPLE ATTEMPTS TO RESUME INFUSION, INCLUDING PUMP POWERED ON/OFF, TUBING REMOVED/RELOADED, AIR SENSOR WIPED WITH ALCOHOL WIPE, PUMP POSITION CHANGED. PUMPS WERE IN SPACE STATION AS THE UNIT DOESN'T HAVE POLE CLAMPS. ALL UNSUCCESSFUL. UNABLE TO SUBMIT TUBING SET DUE TO HAZARDOUS MED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462965 ↗
• MalfunctionMay 9, 2024Device Misassembled During Manufacturing /Shipping; Material Deformation; Air/Gas in Device; Device Misassembled During Manufacturing /Shipping; Material Deformation; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION. (B)(6) SURGICAL ICU AIR IN LINE ALARM. DETAILED INQUIRY DESCRIPTION: MAGNESIUM ADMINISTRATION WITHOUT ASV; AIR IN LINE ALARM OCCURRED; DURING TROUBLESHOOTING NOTICED TUBING WAS PINCHED AND GREEN CLIP NOT INSERTED PROPERLY. ASSISTED RN IN CORRECTING THIS. DURING REROUND HE REPORTS HE DID NOT HAVE ANY FURTHER ALARMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281509 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY USER FACILITY: BRIEF INQUIRY DESCRIPTION. UMSJ AIR IN LINE ALARM. DETAILED INQUIRY DESCRIPTION: AMIOTERONE WITH ASV AIR IN LINE ALARM; LARGE AIR BUBBLE NOTED IN LINE; CLEARED THROUGH TROUBLESHOOTING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281351 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY USER FACILITY: BRIEF INQUIRY DESCRIPTION UMMC PEDS ICU AIR IN LINE ALARM DETAILED INQUIRY DESCRIPTION CLINDAMYCIN ADMINISTERED WITHOUT ASV; AIR IN ALARM OCCURRED; TROUBLESHOOTING RESOLVED PROBLEM NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281349 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY USER FACILITY: BRIEF INQUIRY DESCRIPTION UMMC MEDICAL ICU AIR IN LINE ALARM DETAILED INQUIRY DESCRIPTION D10 ADMINISTERED NO ASV; AIR IN LINE ALARM; AIR VISIBLE WITHIN TUBING; TROUBLESHOOTING RESOLVED ISSUE AFTER MULTIPLE ALARMS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281348 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY USER FACILITY: BRIEF INQUIRY DESCRIPTION. UMMC PEDS ICU AIR IN LINE ALARM. DETAILED INQUIRY DESCRIPTION TPN TRANSFUSING; ASV BEING USED; AIR IN LINE ALARM WITH VISIBLE AIR BUBBLE; RESOLVED WITH TROUBLESHOOTING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281347 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY USER FACILITY: DETAILED INQUIRY DESCRIPTION VANCOMYCIN ADMINISTERED WITH ASV; AIR ACCUMULATION ALARM THAT WAS RESOLVED WITH TROUBLESHOOTING NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281278 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  BRIEF INQUIRY DESCRIPTION: UMMS SURGICAL ICU AIR IN LINE ALARM DETAILED INQUIRY DESCRIPTION: AIR IN LINE ALARM WITHOUT USE OF ASV; TROUBLESHOOTING CORRECTED ISSUE NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281259 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION AIR IN LINE DETAILED INQUIRY DESCRIPTION VANCOMYCIN BEING ADMINISTERED; ASV IN USE; ACCUMULATED AIR IN LINE ALARM; TROUBLESHOOTING RESOLVED NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280819 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIR IN LINE ALARM. DETAILED INQUIRY DESCRIPTION PROP 1000MG/100ML DOSE 25MCG/KG/MIN TRANSFUSING; ASV BEING USED; AIL ALARM TRIGGED, TROUBLESHOOTING RESOLVED ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280705 ↗
• MalfunctionMay 9, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION PATIENT WAS RECEIVING AMICAR 1G/250ML. BBRAUN EDUCATOR CALLED TO ROOM BY RN STATING PUMP INFUSED 50ML AND THEN STOPPED. AFTER WALKING THROUGH HER PROCESS, SHE REALIZED SHE ACCIDENTALLY PROGRAMMED A BOLUS OF 1G/50ML. HER ORDER WAS FOR 1G/250MG AND THAT CONCENTRATION WAS MISSING FROM THE DL. SHOWED HER HOW TO PROGRAM A MEDICATION IF ITS MISSING FROM THE LIBRARY WITH BASIC INFUSION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280357 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION AIR IN LINE ALARM DETAILED INQUIRY DESCRIPTION D5 ADMINISTERED WITHOUT ASV; THE ALARM WAS AIR IN LINE AIR BUBBLE ALARM. WE DID NOT SEE AIR BUBBLE IN THE TUBING SO I ASKED FOR HER TO OPEN THE DOOR SO WE COULD INSPECT THE SENSOR. MULTIPLE BUBBLES WERE SEEN AT THE JUNCTION AND I ASKED THAT SHE REMOVE THE TUBING. I OBSERVED HER ATTEMPT TO REMOVE THE TUBING WITHOUT PRESSING THE GREEN BUTTON- I STOPPED HER AND HAD HER PRESS THE BUTTON FIRST. SHE WAS ABLE TO FLICK THE SMALL BUBBLES FROM THAT AREA AND DISPLACE WITHOUT NEEDING TO PRIME. WHEN REINSERTING THE TUBING I OBSERVED IMPROPER LOADING. I WALKED THIS RN THROUGH HOW TO LOAD AND UNLOAD TUBING PROPERLY. I RE-ROUNDED WITH HER AT 1145 AND SHE STATES THERE HAVE BEEN NO FURTHER ALARMS. SHEN STATES IT IS GOING BETTER SINCE PROPER LOADING AND SET UP OF TUBING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280324 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION AIR IN LINE ALARM DETAILED INQUIRY DESCRIPTION AMICAR 1G/250ML BEING INFUSED; NO ASV; AIR IN LINE ALARM; AIR NOTED IN LINE; TROUBLESHOOTING RESOLVED PROBLEM NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280323 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION AIR IN LINE ALARM DETAILED INQUIRY DESCRIPTION AIR IN LINE ALARM WITH THE USE OF ASV DESCRIPTION OF THE PATIENT EVENT NOREPINEPHRINE 8MG/250ML PT. DOSE WAS .02 MCG/KG/MIN; AIR IN LINE ALARM WITH THE USE OF ASV. AIR NOTED IN TUBING, TAPPED THE AIR BUBBLE TO THE BAG. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280322 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION UMMS MICU AIR IN LINE ALARM DETAILED INQUIRY DESCRIPTION DAPTOMYCIN 1250MG/150ML, NO ASV, AIR IN LINE ALARM, AIR NOTED IN TUBING; RESOLVED WITH TROUBLESHOOTING. MEDICATION ARRIVES TO UNIT COLD. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280040 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION AIR IN LINE ALARM OCCURRED ON NOREPI TRANSFUSION WITHOUT THE USE OF AN ASV. TROUBLESHOOTING DID NOT WORK; AIR IN LINE ALARM CONTINUED TO OCCUR. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279104 ↗