Infusomat® 490105Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 04046964186165), received between Nov 21, 2016 and Sep 14, 2026 — classified as 1 injury, 173 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (71 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. 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. 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 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752516 ↗
• MalfunctionJul 9, 2026Device Alarm System; Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761856 ↗
• MalfunctionJul 9, 2026Device Alarm System; Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761855 ↗
• MalfunctionJul 9, 2026Device Alarm System; Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761848 ↗
• MalfunctionJun 23, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY THE BLOOD PUMP SET CARESITE WAS LEAKING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595457 ↗
• MalfunctionMay 24, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "HALFWAY THROUGH THE TRANSFUSION, PUMP KEPT INDICATING "AIR IN LINE". ALL METHODS OF TROUBLESHOOTING APPLIED TO NO AVAIL. WHEN USING A BLOOD WARMER, THERE IS APPROXIMATELY 50CC OF BLOOD IN THE TUBING. WITHOUT BEING ABLE TO RESOLVE THE FALSE "AIR IN LINE" MESSAGE (THERE WAS NO AIR VISUALIZED IN THE LINE WHEN I REMOVED IT FROM THE PUMP AND INSPECTED IT), WE ARE GOING TO WASTE, AT MINIMUM, 50CC OF BLOOD. IN ORDER TO SALVAGE SOME OF THE BLOOD, I MANUALLY SQUEEZED THE SALINE BACK TO TRY TO PUSH BLOOD DOWN THE LINE TO THE POINT OF THE CONNECTION OF THE IV TUBING TO THE BLOOD WARMER TUBING. AT THIS POINT, WE HAD TO GET A NEW BLOOD TUBING TO REPLACE THE ONE INDICATING FALSE AIR IN LINE. THANKFULLY BLOOD BAGS HAVE TWO AVAILABLE PORTS TO SPIKE, IF THEY DID NOT, WE WOULD HAVE HAD TO HAVE THROWN OUT THE ENTIRE REMAINING UNIT OF BLOOD BECAUSE THE FIRST SPIKE CANNOT BE REMOVED (I TRIED). SO NOW, WE HAVE ONE "FAULTY" TUBING LINE HANGING FROM THE BLOOD BAG WHILE THE NEW LINE IS USED TO COMPLETE THE INFUSION. AT THE VERY LEAST, THE PATIENT DID GET THE REMAINDER OF THE UNIT OF BLOOD AND NO HARM WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267014 ↗
• MalfunctionMay 14, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE TUBING DETACHED AT PUMP SEGMENT DURING BLOOD TRANSFUSION. BLOOD LEAKAGE WAS EXPERIENCED DURING THE DETACHMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25179373 ↗
• MalfunctionMay 11, 2026Leak/Splash; Device Misassembled During Manufacturing /Shipping

  AS REPORTED BY THE USER FACILITY: DURING PREPARATION FOR A BLOOD TRANSFUSION, THE PRIMARY REGISTERED NURSE (RN) OBSERVED THAT THE FREE FLOW CLIP APPEARED TO BE ASSEMBLED BACKWARDS ON THE BLOOD SET. WHEN THE NURSE ATTEMPTED TO PLACE THE TUBING INTO THE PUMP, LEAKAGE WAS OBSERVED AROUND THE FREE FLOW CLIP AREA. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142795 ↗
• MalfunctionApr 27, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AFTER PRIMING BLOOD TUBING, AIR IN LINE. AFTER GETTING AIR OUT VIA SYRINGE REMOVAL OF BLOOD. AIR FROM BAG TO FILTER AND AIR AFTER PORT ON BLOOD TUBING. AIR FOUND IN PIV CONNECTED TUBING. BLOOD REMOVED FROM TUBING VIA SYRINGE. AIR REMOVED FROM PIV. BLOOD GIVEN VIA SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000054 ↗
• MalfunctionApr 10, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: IV PUMP ALARMED 'AIR ACCUMULATION'. STAFF OPENED PUMP TO ASSESS AND FOUND BLOOD LEAKING FROM LINE LOADING GUIDE (WHITE RECTANGULAR PLASTIC CLIP). STAFF IMMEDIATELY CLAMPED LINE AND DISCONNECTED FROM PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839707 ↗
• MalfunctionMar 26, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: "BLOOD TRANSFUSION SET LEAKING". IMPACT TO PATIENT: DELAY IN TREATMENT, RISK FOR INFECTION/INTRODUCTION OF CONTAMINANTS. ACTION(S) TAKEN TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION/FLUID BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699778 ↗
• MalfunctionMar 10, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AFTER PRIMING BLOOD TUBING, AIR IN LINE. AFTER GETTING AIR OUT VIA SYRINGE REMOVAL OF BLOOD. AIR FROM BAG TO FILTER AND AIR AFTER PORT ON BLOOD TUBING. AIR FOUND IN PIV CONNECTED TUBING. BLOOD REMOVED FROM TUBING VIA SYRINGE. AIR REMOVED FROM PIV. BLOOD GIVEN VIA SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557791 ↗
• MalfunctionMar 9, 2026Leak/Splash

  AS REPORTED VIA MEDWATCH NUMBER MW5183018: DESCRIBE EVENT OR PROBLEM: THE INFUSOMAT SPACE PUMP Y-TYPE BLOOD SET TUBING WAS LEAKING AT THE PORT SITE. REQUIRED REPLACEMENT FOR BLOOD TRANSFUSION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544156 ↗
• MalfunctionFeb 16, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AIR IN LINE MULTIPLE ERRORS EVEN WHEN CHANGING PUMPS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24348579 ↗
• MalfunctionFeb 4, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: ALARM EVENTS AIR IN LINE - NOT VISIBLE AND UNRESOLVED. DETAILS OF COMPLAINT (REPORTED ISSUE): CONSTANT BEEPING "AIR IN LINE" WHILE GIVING A BLOOD TRANSFUSION. HAPPENED DURING 2 SEPARATE BLOOD TRANSFUSIONS. SIGNIFICANT DELAY IN ADMINISTERING THE BLOOD. IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, OTHER. OTHER PATIENT IMPACT DELAY IN BLOOD TRANSFUSION ADMINISTRATION, ONLY HAVE 4 HOURS TO INFUSE. INFUSION ORDERED OVER 3 HOURS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, OTHER. MEDICATION/FLUID BLOOD. IV RATE 148 ML/H.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257385 ↗
• MalfunctionFeb 4, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: ALARM EVENTS AIR IN LINE - NOT VISIBLE AND UNRESOLVED. DETAILS OF COMPLAINT (REPORTED ISSUE): CONSTANT BEEPING "AIR IN LINE" WHILE GIVING A BLOOD TRANSFUSION. HAPPENED DURING 2 SEPARATE BLOOD TRANSFUSIONS. SIGNIFICANT DELAY IN ADMINISTERING THE BLOOD. IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, OTHER. OTHER PATIENT IMPACT DELAY IN BLOOD TRANSFUSION ADMINISTRATION, ONLY HAVE 4 HOURS TO INFUSE. INFUSION ORDERED OVER 3 HOURS. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, OTHER. MEDICATION / FLUID BLOOD. IV RATE 148 ML/H.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257384 ↗
• MalfunctionFeb 3, 2026Degraded; Mechanical Jam; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: USER SAID THAT THEY HAD SEVERAL TUBING'S THAT WOULD NOT FIT INTO THE PUMP. SAID THE TUBING WAS BIGGER AND KEPT GIVING AN AIR ALARM. THEY ALSO STATED THAT ONE OF THE TUBING HAD A HOLE IN THE TUBING SECTION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246108 ↗
• MalfunctionJan 29, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: TUBING WAS PRIMED WITH SALINE ACCORDING TO DRUG ADMINISTRATION INSTRUCTIONS. TUBING WAS THEN CONNECTED TO PATIENT'S PORT. CART INFUSION STARTED, AND PATIENT IMMEDIATELY REPORTED FEELING WATER DRIPPING ON HIS ABDOMEN WHERE THE TUBING WAS RESTING. TUBING INSPECTED AND NOTED TO BE LEAKING FROM THE DISTAL VALVE CONNECTION AT BOTTOM Y-SITE (PROMIXAL VALVE TO THE PATIENT). INFUSION STOPPED IMMEDIATELY AND TUBING SWITCHED. HOWEVER, 1 ML OF CAR T INFUSION WAS LOST WHEN SWITCHING TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209933 ↗
• MalfunctionJan 13, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: PATIENT WAS WALKING AROUND THE HALLS AND NOTICED THAT HIS PUMP WAS LEAKING. RN LOOKED AT THE TUBING INSERTED INTO THE CHANNEL AND FOUND THAT THE TUBING WAS LEAKING. PATIENT WAS ONLY ABLE TO GET HALF OF THEIR BAG OF PACKED RED CELLS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054144 ↗
• MalfunctionDec 10, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: WHILE PATIENT WAS RECEIVING BLOOD THROUGH IV, IT WAS OBSERVED THAT BLOOD WAS LEAKING FROM THE TUBING. UPON FURTHER EVALUATION, THE TUBING WAS SEVERED AND SNAPPED IN TWO CAUSING THE BLOOD TO LEAK ONTO THE BED AND NOT INTO THE PATIENT. NEW BLOOD HAD TO BE ORDERED, DELAYING ADMINISTRATION OF PRBC TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771188 ↗
• MalfunctionDec 5, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: OTHER DETAILS BLOOD TRANSFUSION WAS COMPLETED. BEDSIDE NURSE OPENED THE B BRAUN PUMP DOOR TO REMOVE BLOOD SET. BLOOD STARTED POURING OUT OF THE TUBING OVER THE PUMP, THE PUMPS UNDERNEATH IT AND ONTO THE FLOOR. TUBING HAD BROKEN AT THE INFERIOR END OF THE LINE LOADING GUIDE. OTHER ACTIONS TAKEN BLOOD TUBING REMOVED AND DISCARDED. MEDICATION / FLUID PACKED RED BLOOD CELLS. IV RATE 300ML/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727309 ↗
• MalfunctionNov 12, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BLOOD LEAKED FROM THE BACKFLOW DEVICE AT THE END OF THE BLOOD ADMINISTRATION TUBING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534513 ↗
• MalfunctionNov 12, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY BLOOD LEAKED FROM INSIDE PUMP WHILE INFUSING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531649 ↗
• MalfunctionNov 5, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: WENT TO GIVE PLATELETS AND PRIMED THE TUBING. ONCE PLATELETS WERE RUNNING TUBING FILLED WITH AIR. LINE WAS UNABLE TO BE USED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478324 ↗
• MalfunctionNov 5, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY RN PRIMED 490105 WITH SALINE AND BLOOD, LOADED PUMP AND STARTED INFUSION. NOT LONGER AFTER PATIENT SAID THAT BLOOD WAS LEAKING. RN LOOKED FOR LEAK AND SAID THE BLOOD WAS LEAKING FROM UNDER THE IV PUMP AND STARTED DRIPPING ON THE FLOOR. WHEN RN WENT TO TAKE OUT TUBING, THE TUBING SEPARATED ON THE LEFT SIDE OF THE LINE LOADING GUIDE. BLOOD SPLATTERED EVERYWHERE (INSIDE AND OUTSIDE THE PUMP) CAUSING DELAY IN INFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478278 ↗