Infusomat® 490103Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 04046964302107), received between Jul 17, 2018 and Jun 15, 2026 — classified as 1 injury, 107 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (36 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-2400-2024 · 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE ISSUE REPORTED CONCERNS A LEAKAGE OBSERVED AT THE CONNECTION POINT BETWEEN TWO TUBING SECTIONS AFTER RESTARTING THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500687 ↗
• MalfunctionMay 26, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE HAZARDOUS MEDICATION WAS LEAKING OUT OF THE IN-LINE FILTER AND DRIPPED ON THE PATIENT.

  Patient problems: Chemical Exposure

  MAUDE report 25280806 ↗
• MalfunctionMay 24, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT UPON INSPECTING THE TPN IV TUBING IT WAS NOTICED THAT 1.5 INCH OF AIR WAS WITHIN THE TUBING CHAMBER. AIR WAS THEN DRAWN OUT THROUGH THE SYRINGE AND AIR CONTINUED TO ACCUMULATE WITHIN THE PUMP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25266963 ↗
• MalfunctionMay 24, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "FROM INITIAL START PUMP BEEPING ACCUMULATED AIR. WAS BEEPING BEFORE DRUG EVEN REACHED THE MACHINE. NO AIR NOTED IN LINE. TUBING WHERE GREEN CLAMP (THAT GET INSERTED INTO THE MACHINE) WAS VERY KINKED FROM PACKAGE. NOT NOTED UNTIL ISSUES AROSE. I TRIED TO MASSAGE LINE, UNABLE TO STRAIGHTEN KINKS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25266896 ↗
• MalfunctionMay 11, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE VENT FELL OUT WHILE PRIMING THE TUBING WITH TAXOL (A HAZARDOUS MEDICATION) LEAKED OUT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142733 ↗
• MalfunctionMay 11, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DURING THERAPY, A REGISTERED NURSE (RN) WAS CALLED TO THE PATIENT'S ROOM DUE TO EXCESS AIR OBSERVED IN THE LIPID TUBING WITHOUT A CORRESPONDING AIR IN LINE ALARM FROM THE PUMP. THE NURSE CLAMPED THE LIPID TUBING AND INITIATED REPLACEMENT OF THE PUMP. UPON REMOVING THE LIPID TUBING FROM THE PUMP, THE TUBING WAS OBSERVED TO BE SLICED AT THE POINT OF EXIT INSIDE THE PUMP, WHICH ALLOWED AIR TO ACCUMULATE WITHIN THE LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136307 ↗
• MalfunctionMay 6, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: NEW PIV LINES PRIMED WITH D10W WHILE REPLACING THE BAG. AT ABOUT 0600 BEDSIDE RN NOTICED IV BLEEDING BACK. RESOURCE RN CALLED TO BEDSIDE. ALL LINE CLAMPS AND PUMP SETTINGS CHECKED. FOUND PART OF LINE WITH AIR IN IT ABOVE THE FILTER, AND AIR IN THE QUAD-SET CLOSE TO PATIENT. FILTER WAS FOUND WITH FLUID IN IT. BEDSIDE RN PRIMED THE LINE PRIOR TO PLACEMENT. PATIENT IV UNHOOKED FROM LINE AND FLUSHED WITH NO DIFFICULTY. IV REMAINED INTACT. REPLACED LINE. CARE RESUMED. NO SPECIFIC CRACK IN THE LINE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097406 ↗
• MalfunctionApr 22, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AIR IN LINE ALARM, UNABLE TO INFUSE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955610 ↗
• MalfunctionMar 24, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: WHEN PATIENT WENT TO THE BATHROOM WITH APPROX 139.5 ML LEFT IT WAS NOTED THAT TAXOL WAS DRIPPING OUT OF THE FILTER. IT WENT FROM THE BATHROOM TOILET TO THE CHAIR IN HER ROOM AND ACROSS THE HALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673730 ↗
• MalfunctionMar 24, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: "FOUND PATIENTS PILLOW WET. HIS IV WAS LEAKING FROM THE PURPLE LEUR ACCESS DEVICE. I HAD TO RESTART HIS LEVO GTT FOR HYPOTENSION AND TITRATED UP TO 7 MCG WHEN THIS WAS DISCOVERED. YOU COULD SEE IT LEAKING OUT THE SIDE, IT COULD HAVE BEEN A CRACK." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673729 ↗
• MalfunctionMar 20, 2026Crack; Fluid/Blood Leak; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: "ARRIVED AT BEDSIDE FOR REPORT AND UPON DUAL SIGNING FLUIDS AND TRACING IV TUBING, NOTICED THAT LARGE BORE IV TUBING RUNNING CLEAR KVO FLUIDS WAS DRIPPING. TRACED DRIP BACK TO ITS ORIGIN. TUBING NOTED TO HAVE A CRACK ON BOTH SIDES. SITE OF CRACK WAS JUST DISTAL TO IV PUMP AND IV TUBING INSERTION BUT FAR FROM PATIENT AND CRIB. AIR ALSO NOTED IN LINE AT THIS TIME. TUBING REMOVED AND NEW TUBING WITH NEW BAG OF FLUID HUNG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650336 ↗
• MalfunctionMar 12, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: THE PRODUCT CAME APART INSIDE OF THE PUMP CAUSING BUBBLES IN THE LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578279 ↗
• MalfunctionJan 30, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): NURSE DISCOVERED BROWN MATTER IN TUBING / FILTER. REMOVED PROMPTLY AND REPLACED TUBING. 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 TPN BASICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222575 ↗
• MalfunctionJan 27, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DURING THERAPY PATIENT IV PUMP WITH TPN ALARMED "ACCUMULATED AIR EXCEEDED." AFTER PAUSING THE DRIP AND CLAMPING THE LINE, IT WAS NOTED A SMALL PUDDLE OF YELLOW LIQUID ON THE FLOOR AND THE FRONT/UNDER SIDE OF THE PUMP WET TO THE TOUCH. AFTER FURTHER ASSESSMENT, THE CASSETTE WAS REMOVED FROM THE IV POLE AND FOUND THE TUBING TO BE SEVERED BY THE GREEN CLAMP THAT GETS INSERTED INTO THE PUMP. PATIENT GLUCOSE WAS ASSESSED AT THIS TIME AND NEW TUBING WAS PRIMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188320 ↗
• MalfunctionDec 19, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT OR PROBLEM: AFTER SPIKING AND PRIMING FILTERED TUBING OVER THE PUMP AND PROGRAMMING IT, RN WENT AND FLUSHED THE PATIENT'S IV AND CONNECTED THE TUBING. IMMEDIATELY AFTER CONNECTING THE TUBING, BUT BEFORE RN HIT START ON THE PUMP, BLOOD BACKED UP QUICKLY INTO THE TUBING. IT WAS A FOREARM PIV. THE BLOOD BACKED UP INTO A SPACE OF AIR AT THE START OF THE TUBING THAT WAS NOT THERE WHEN RN PRIMED THE LINE ON THE PUMP. RN STATED, "I ALWAYS DOUBLE CHECK MY LINES FOR BUBBLES." RN FULLY PRIMED THE TUBING AND SAW THE MEDICATION DRIPPING OUT OF THE END. SOMEHOW IN THE SHORT TIME BETWEEN SETTING UP PUMP AND CONNECTING IT TO THE PATIENT, AIR ACCUMULATED AT THE END OF IV LINE. WHEN RN SAW THE QUICK BLOOD RETURN RN IMMEDIATELY DISCONNECTED THE TUBING AND FLUSHED THE BLOOD IN THE IV. RN GOT A NEW BAG WITH A NEW LINE, SET UP IN THE SAME EXACT WAY, WITH NO ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853628 ↗
• MalfunctionNov 11, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WHEN DISCONNECTING AN INTERMITTENT MEDICATION, THE RN NOTICED MANY AIR BUBBLES IN THE TUBING OF THE TPN DISTAL TO THE IV PUMP, THE LINE WAS CLAMPED, IV TUBING UNLOADED FROM PUMP TO REMOVE AIR, THE RN FOUND THAT THE TUBING HAD BEEN SEVERED BY THE PUMP. PROVIDER NOTIFIED, NEW FLUIDS ORDERED AND HUNG. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526905 ↗
• MalfunctionNov 8, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WHEN DISCONNECTING AN INTERMITTENT MEDICATION, THE RN NOTICED MANY AIR BUBBLES IN THE TUBING OF THE TPN DISTAL TO THE IV PUMP, THE LINE WAS CLAMPED, IV TUBING UNLOADED FROM PUMP TO REMOVE AIR, THE RN FOUND THAT THE TUBING HAD BEEN SEVERED BY THE PUMP. PROVIDER NOTIFIED, NEW FLUIDS ORDERED AND HUNG. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23505319 ↗
• MalfunctionSep 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: 0.2 MICRON FILTER (PAL FILTER) LEAKED, AND A BUG WAS ALSO FOUND IN SET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038030 ↗
• MalfunctionSep 12, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: STERILE LINE CHANGE PERFORMED FOR PATIENT'S PICC LINE. HAL PUMP CONTINUED ALARMING "AIR" DESPITE BEING CLEARED WITH 6ML REPEATEDLY SEVERAL TIMES. SMALL PUDDLE OF HAL NOTED UNDER THE PUMP STAND. NEW HAL TUBING OBTAINED AND STERILELY PRIMED AND CHANGED AND NO "AIR ALARM SOUNDED AFTER TUBING CHANGE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037848 ↗
• MalfunctionSep 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: 0.2 MICRON FILTER (PAL FILTER) LEAKED, AND A BUG WAS ALSO FOUND IN SET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026847 ↗
• MalfunctionAug 8, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: VENT DETACHED CAP ON PUMP SET CAUSING CHEMO LEAK. DETAILED INQUIRY DESCRIPTION: CUSTOMER STATES: I THINK THE CAP FROM THE VENT FELL OFF THE FILTERED TUBING. NOT SURE IF IT WAS LOOSE. WHEN THE NURSE REMOVED THE CHEMO FROM THE BAG, SHE DID NOT NOTICE THE CAP WAS MISSING. HOWEVER, WE LATER FOUND THE CAP WAS IN THE DOUBLE PLASTIC BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22756291 ↗
• MalfunctionJun 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: SPECK OF BLACK SOMETHING IN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318356 ↗
• MalfunctionMay 5, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "THE DRUG TOOK AND ADDITIONAL 40 MINUTES TO INFUSE. WHILE OPENING CLAMPS TO ENSURE THERE ARE NO AIR BUBBLES, DRUG MAY RUN TOO QUICKLY. EMOTIONAL DISTRESS TO PT AND STAFF. ONE NURSE TAKEN "OUT OF STAFFING" AS IT REQUIRED SO MUCH ATTENTION" 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. FLICKED AIR BUBBLES. MEDICATION / FLUID: PACLITAXEL. IV RATE: 100ML/HR AND 330MLS/HR. OTHER DETAILS: THE DRUG TOOK AN ADDITIONAL 40 MINUTES TO INFUSE. WHILE OPENING CLAMPS TO ENSURE THERE ARE NO AIR BUBBLES, DRUG MAY RUN TOO QUICKLY. EMOTIONAL DISTRESS TO PT AND STAFF. ONE NURSE TAKEN "OUT OF STAFFING" AS IT REQUIRED SO MUCH ATTENTION. ALARM EVENTS: AIR IN LINE, NOT VISIBLE AND UNRESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961024 ↗
• MalfunctionMar 29, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: WE HAD 2 INSTANCES OF CHEMO SPILLS DUE TO LEAKING AT THE FILTER OF TUBING (REF. (B)(4): INFUSOMAT SPACE PUMP IV SET). WHILE WE ARE NOT SURE OF THE LOT, WE SUSPECT LOT # 0061960804. HOWEVER, IT COULD ALSO HAVE BEEN LOT # 0061961590, 0061956308 OR 0061966559. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727538 ↗
• MalfunctionMar 29, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: WE HAD 2 INSTANCES OF CHEMO SPILLS DUE TO LEAKING AT THE FILTER OF TUBING (REF. (B)(4): INFUSOMAT SPACE PUMP IV SET). WHILE WE ARE NOT SURE OF THE LOT, WE SUSPECT LOT # 0061960804. HOWEVER, IT COULD ALSO HAVE BEEN LOT # 0061961590, 0061956308 OR 0061966559. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727537 ↗