Infusomat® 490100Recalls & reported problems

Summary

The FDA's MAUDE database contains 408 adverse event reports that list this exact device (DI 04046964186080), received between Jan 9, 2017 and Sep 29, 2026 — classified as 2 deaths, 9 injuries, 397 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (239 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.

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 · FDA record ↗

2. 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-2397-2024 · Root cause: Process control · FDA record ↗

3. 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 408 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937115 ↗
• MalfunctionSep 29, 2026Leak/Splash

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50927922 ↗
• MalfunctionSep 23, 2026Leak/Splash

  As reported by the user facility:30 minutes after etoposide was started RN went into the patient's room and noticed a wet spot underneath the tubing where the chemo was infusing through. The etoposide was running into the Y-site of the fluid line (through equashield) closest to the patient. The leak was at this connection point, despite all connection points with the equashield being tightened all the way. Chemo line disconnected from the fluid line and was reconnected directly to the patient to finish the infusion. The spill did not touch the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867042 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777880 ↗
• MalfunctionAug 25, 2026Leak/Splash

  Patient problems: Chemical Exposure

  MAUDE report 50429375 ↗
• MalfunctionAug 24, 2026Free or Unrestricted Flow; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410563 ↗
• MalfunctionJun 8, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: SALINE WAS LEAKING FROM LOCKSITE ON THE ARTERIAL LINE DURING PRIMING. UNABLE TO STOP. LINE WAS NOT USED. DURING INITIAL SET UP, NS WAS LEAKING FROM THE ATRIAL MED/ BLOOD PORT- UNABLE TO GET IT TO STOP BY ADJUSTING CAP. LINES NOT USED FOR PATIENT CARE. PATIENT INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429170 ↗
• MalfunctionMay 26, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: "STARTING THE FLUSH AND THE PRIMARY PUMP WAS BEEPING WITH AN AIR BUBBLE. I OPENED UP THE PUMP AND THE TUBBING WAS BROKEN IN HALF. THIS DID NOT AFFECT THE PATIENT IN ANY WAY. THE PRIMARY INFUSION OF THE REMICADE WAS COMPLETED WHICH IS WHAT THE TUBING BEING USED WAS FOR. THERE WAS NO INFILTRATION OR PHLEBITIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280826 ↗
• MalfunctionMay 26, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY. PARTICULATE MATTER WAS OBSERVED IN THE CARESITE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280448 ↗
• MalfunctionMay 6, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: UPON DISCONNECTING OR FLUID TUBING THAT WAS Y'D INTO PT'S INFUSING MAINTENANCE FLUIDS, BLOOD BEGAN TO BACK UP INTO THE PT'S PIV AND INTO MAINTENANCE TUBING. IT RAPIDLY BACKED UP TO THE SITE OF THE FIRST CONNECTOR PORT FOR MEDICATION ADMINISTRATION AND THEN BEGAN COMING OUT OF THE PORT AND ONTO THE PT'S BED LINEN. DURING THIS THE MAINTENANCE FLUIDS WERE STILL INFUSING AT 70 ML/HR PER ORDER IN THE MAR. UPON NOTICING THE BLOOD COMING OUT OF THE PORT THE PT'S PIV WAS CLAMPED AND THE MAINTENANCE FLUIDS WERE PAUSED. THE TUBING WAS REPLACED, BED LINENS CHANGED AND PT'S MAINTENANCE FLUIDS RESUMED WITHOUT FURTHER INCIDENCE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104555 ↗
• MalfunctionApr 22, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: "WE HAD A CHEMO SPILL, WHICH LED TO A SPLASH AND EXPOSURE TO AN EMPLOYEE. THE EMPLOYEE OPENED THE VENT LOCATED ON THE TOP OF THE DRIP CHAMBER WHICH ENDED UP POPPING OFF COMPLETELY. CHEMOTHERAPY THEN STARTED TO LEAK OUT OF THE VENT HOLE ONTO THE EMPLOYEES HAND AND ARM.".

  Patient problems: Chemical Exposure

  MAUDE report 24954493 ↗
• MalfunctionApr 11, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 3: TOTAL OF 4 AIR IN LINE ALARMS FOR NOREPINEPHRINE (MICRO-BUBBLES PRESENT). NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852002 ↗
• MalfunctionApr 11, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE VENT CAP CAME OFF TUBING USED FOR CHEMO. THE WHOLE PLASTIC PIECE CAME OUT, SO THAT THERE WAS A DIRECT OPENING TO THE IV FLUID, AND IT LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851447 ↗
• MalfunctionApr 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: TOTAL OF 4 AIR IN LINE" ALARMS FOR NOREPINEPHRINE (MICRO-BUBBLES PRESENT). NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845403 ↗
• MalfunctionApr 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: TOTAL OF 4 AIR IN LINE" ALARMS FOR NOREPINEPHRINE (MICRO-BUBBLES PRESENT). NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845192 ↗
• MalfunctionApr 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 4: TOTAL OF 4 AIR IN LINE" ALARMS FOR NOREPINEPHRINE (MICRO-BUBBLES PRESENT). NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839638 ↗
• MalfunctionApr 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: "PATIENT ON A TOTAL OF 1.8 MCG/KG/MIN NOREPINEPHRINE (INCREDIBLY HIGH DOSE) AS WELL AS 0.3 MCG/KG/MIN EPINEPHRINE AND 2.4 UNITS/HR VASOPRESSIN. VERY UNSTABLE PATIENT. TOTAL OF 4 AIR IN LINE" ALARMS FOR NOREPINEPHRINE MICRO-BUBBLES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838744 ↗
• MalfunctionApr 7, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: FOREIGN MATTER OBSERVED IN THE FLUID PATH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809679 ↗
• MalfunctionApr 2, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: RN PRIMED PRBC TUBING ON THE PUMP PER PROTOCOL. PUMP KEPT BEEPING "AIR BUBBLE ALERT". RN TRIED MULTIPLE TIMES TO RESOLVE THE ISSUE BY SWITCHING OUT PUMPS, FLICKING THE TUBING, PRIMING THROUGH, TURNING THE PUMP, ETC. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765570 ↗
• MalfunctionMar 26, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: A LARGE AMOUNT OF AIR WAS FOUND IN THE IV TUBING THAT WAS ATTACHED TO PATIENTS ARTERIAL LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706058 ↗
• MalfunctionMar 19, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: RN WAS COMPLETING PATIENT CARE AND SAFETY CHECKS AT 0715 WHEN SHE NOTICED THAT THE FLOOR WAS STICKY NEAR THE PATIENT'S IV POLE. UPON FURTHER INSPECTION, THERE WERE PUDDLES OF TPN ON THE FLOOR AND ON/IN THE B BRAUN PUMPS. TPN TUBING WAS CLAMPED AND PUMP WAS OPENED TO INSPECT THE LEAK. THERE WAS A LARGE LEAK NOTED NEAR THE GREEN CLAMP PIECE (THE PART THAT LOOKS LIKE A BIRD BEAK) OF THE IV TUBING THAT INSERTS INTO THE PUMP. TPN WAS LEAKING OUT AT THIS PART AND INTO THE PUMP, PUMPS BENEATH, AND THE FLOOR BELOW. THERE WAS ALSO AN AIR BUBBLE NOTED HERE. THIS TUBING WAS REMOVED, PROVIDER WAS NOTIFIED, NEW FLUIDS WERE ORDERED AND THIS FLUID/TUBING AND THE IV PUMP WAS TAKEN DOWN AND PLACED IN C4B CLINICAL LEADER OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637701 ↗
• MalfunctionMar 12, 2026Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: WOULD NOT ALLOW IV FLUIDS OR MEDICATION TO INFUSE WITHOUT ALARMING "AIR IN LINE". IV FLUID PRIMED THROUGH PUMP. WOULD NOT RUN NS WITHOUT ALARMING AIR IN LINE. USER ATTEMPTED TO RUN BEVACIZUMAB AS A SECONDARY LINE. CONTINUED TO ALARM AIR IN LINE. USER ATTEMPTED TO ADVANCE AIR IN LINE UTILIZING PUMP, AS WELL AS GRAVITY. NO VISIBLE BUBBLES NOTED. WHEN TUBING REMOVED FROM PUMP - FLEXIBLE AREA NOTED TO BE COMPRESSED AND WRITER UNABLE TO EXPAND. TUBING REINSERTED MULTIPLE TIMES IN PUMP. ULTIMATELY TUBING ENDED UP BEING CHANGED TO A DIFFERENT TUBING AND IT RESOLVED. IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS. ACTION(S) TAKEN FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION / FLUID BEVACIZUMAB AND NS. IV RATE 700ML HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578234 ↗
• MalfunctionFeb 23, 2026Detachment of Device or Device Component; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IV TUBING BECAME DISCONNECTED IN PUMP DURING MED ADMINISTRATION CAUSING LARGE ACCUMULATION OF AIR IN TUBING UNDETECTABLE BY PUMP. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414869 ↗
• DeathFeb 17, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: CODE EVENT AT 1900, WITH ROSC ACHIEVED AFTER APPROXIMATELY 15. FOLLOWING RESUSCITATION, AIR BUBBLES WERE NOTED IN THE IV TRI SET DISTAL TO THE RED PORT WHERE CODE MEDICATIONS HAD BEEN ADMINISTERED. AN AIR POCKET WAS ALSO VISUALIZED IN THE LIPID INFUSION LINE NEAR THE CONNECTION SITE, RAISING CONCERN FOR A POSSIBLE AIR EMBOLISM. HEAD ULTRASOUND REVEALED PNEUMOCEPHALUS, AND TELEMETRY REVIEW WAS SUSPICIOUS FOR A CORONARY EVENT. PICC DRESSING WAS TAKEN DOWN AND THE ENTIRE LINE SETUP WAS CHANGED AND PRESERVED. NOTABLY, A CAP AND LINE CHANGE HAD BEEN PERFORMED APPROXIMATELY 50 MINUTES PRIOR TO THE ARREST. ALL OF THIS RESULTED IN THE PATIENT PASSING AWAY.

  Patient problems: Cardiac Arrest

  MAUDE report 24373027 ↗
• MalfunctionFeb 16, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AIR VISUALIZED IN TUBING. RN NOTICED LARGE AMOUNT OF AIR IN MILRINONE TUBING ABOVE THE PUMP. RN CHANGED TUBING AND UPON DISCONNECTING TUBING REALIZED THAT AIR WAS ALL THROUGHOUT THE TUBING. B BRAUN PUMP DID NOT ALARM. THIS PROMPTED FURTHER INSPECTION OF HEPARIN 2:1 LINE. 3 AREAS OF AIR WAS NOTED POST PUMP. B BRAUN PUMP DID NOT ALARM. HEPARIN 2:1 LINE CHANGED OUT. PICTURES ATTACHED OF HEPARIN LINE. LINES AND PUMPS SAVED AND IN CLINICAL LEADER OFFICE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349139 ↗