Infusomat® 490102Recalls & reported problems

Summary

The FDA's MAUDE database contains 349 adverse event reports that list this exact device (DI 04046964186127), received between May 3, 2017 and Jun 23, 2026 — classified as 3 deaths, 346 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (91 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-2399-2024 · 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 349 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: TUBING APPEARED TO BE CUT AND WAS LEAKING FLUID INTO PUMP. DRUG USED WAS DECITABINE AND NS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25594876 ↗
• MalfunctionJun 10, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE LINE DETACHED FROM THE MEMBRANE CONNECTION AND RESULTED IN CHEMOTHERAPY LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456073 ↗
• MalfunctionJun 8, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE LINE DETACHED FROM THE MEMBRANE CONNECTION AND RESULTED IN CHEMOTHERAPY LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25432060 ↗
• MalfunctionApr 7, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: CHEMO SPILL RESULTED FROM VENT COMING COMPLETELY OUT OF THE TUBING WHEN THE VENT WAS OPENED. DRUG LOST AND HAD TO RE MIX AND READMINISTER REMAINING MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809844 ↗
• MalfunctionMar 25, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: THE VENT PORT COVER POPS OFF EASILY AND ALLOWS AIR INTO THE TUBING AND MEDICATION OUT. TWO SETS OF TUBING FROM THE SAME LOT WERE TRIED, BOTH HAD THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686714 ↗
• MalfunctionMar 25, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: THE VENT PORT COVER POPS OFF EASILY AND ALLOWS AIR INTO THE TUBING AND MEDICATION OUT. TWO SETS OF TUBING FROM THE SAME LOT WERE TRIED, BOTH HAD THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686713 ↗
• MalfunctionMar 23, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THERE WAS A CHEMO SPILL RELATED TO DEFECTIVE TUBING. THE MEDICATION WAS LEAKING FROM A PART OF THE AIR VENT THAT POPPED OFF. THE MEDICATION CAUSED AN EXPOSURE. THE CHEMO HAD TO BE REMIXED AND REPRIMED.

  Patient problems: Chemical Exposure

  MAUDE report 24661301 ↗
• MalfunctionFeb 20, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN TUBING FOUND AFTER THE PUMP. NO ALARM OCCURRED". "AIR IN LINE PAST THE PUMP.". IMPACT TO PATIENT: DELAY IN TREATMENT, UNDER DOSING OF ORDERED MEDICATION / FLUIDS. ACTION(S) TAKEN REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405830 ↗
• MalfunctionFeb 20, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE DETECTED AFTER THE PUMP". ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), OTHER. OTHER ACTIONS TAKEN CHANGED OUT TUBING AS TUBING WAS ALREADY INFUSING. MEDICATION / FLUID NS, VANCOMYCIN. IV RATE 114ML/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405699 ↗
• MalfunctionFeb 4, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING CHEMOTHERAPY SET WAS REPORTED TO BE LEAKING FROM THE VENT CAP. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259385 ↗
• MalfunctionJan 27, 2026Leak/Splash; Reflux within Device

  AS REPORTED BY THE USER FACILITY: REASON FOR COMPLAINT: PAL TUBING GOT RESTRUNG AS IS DONE DAILY, PUMP BEGAN BEEPING OFF, WHEN RN CHECKED THE PATIENT THE BLOOD FROM THE ARTERIAL LINE HAD BEEN BACKED UP AND WAS LEAKING OUT OF A PORT OF THE TUBING. CONFIRMED THROUGH FLUSHING AS IT WAS STILL LEAKING OUT OF THAT (CONNECTED BY MANUFACTURER) PORT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188849 ↗
• MalfunctionDec 30, 2025Device Alarm System; Device Alarm System

  ACCORDING TO COMPLAINANT, THAT THE PUMP KEPT BEEPING "AIR IN LINE" ALARM. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927466 ↗
• MalfunctionDec 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY THE LOWEST Y-SITE CAME APART WHILE SWITCHING CHEMO DRUGS. THIS WAS CONNECTED TO THE PATIENT AS THE PRIMARY LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704090 ↗
• MalfunctionNov 18, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY TUBING CRACKED WHILE IT WAS BEING CONNECTED, AT THE LUER LOCK ADAPTER, CAUSING SALINE TO LEAK AND PATIENT'S BLOOD TO BACKFLOW ONTO THE FLOOR. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23582014 ↗
• MalfunctionNov 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DURING THERAPY FOREIGN MATTER THOUGHT TO BE INSIDE DRIP CHAMBER OF THE IV SET BUT NO MATTER DETERMINED. FOREIGN MATTER SEEMS TO BE IMBEDDED IN THE PLASTIC ITSELF POSSIBLY INK OR OTHER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535708 ↗
• MalfunctionNov 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  AS REPORTED BY THE USER FACILITY: END USER REPORTS THAT THE PUMP SEGMENT THAT HOOKS INTO THE INFUSION PUMP WAS PUT UPSIDE DOWN. THE PART DIDN'T LINE WITH THE PUMP AND SO THE FLOW WOULD HAVE GONE THE WRONG WAY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23505320 ↗
• MalfunctionOct 31, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: INFUSION RN HAD AN ISSUE WITH ADMINISTERING THE NAXITAMAB INFUSION WHEN TRYING TO RUN MED ON 3 DIFFERENT INFUSOMAT PUMPS. THE PUMP KEPT ERRORING OUT AND SAYING THAT THERE WAS AIR IN LINE, BUT THERE WERE NO VISIBLE BUBBLES/AIR PRESENT IN THE LINE. BECAUSE NO PUMP WOULD RUN THE INFUSION, WE ENDED UP MANUALLY INFUSING THE MED OFF PUMP BY COUNTING DRIPS, AFTER CALCULATING THE DRIP RATE, AS WASTING THE MED AND REMAKING IT WAS NOT AN OPTION DUE TO COST OF THE MED. THIS SITUATION DELAYED INFUSION FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435368 ↗
• MalfunctionAug 29, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: PATIENT'S PUMP REPORTING AIR IN LINE BUT IT WAS DISCOVERED THAT THE TUBING WAS FAULTY AND LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923916 ↗
• MalfunctionAug 28, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE ALARM, BUT TUBING WAS BROKEN INSIDE THE PUMP." IMPACT TO PATIENT: DELAY IN TREATMENT, EMOTIONAL DISTRESS, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, UNDER DOSING OF ORDERED MEDICATION / FLUIDS, VITAL SIGNS COMPROMISED. OTHER PATIENT IMPACT DELAY IN TREATMENT, EMOTIONAL DISTRESS, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, UNDER DOSING OF ORDERED MEDICATION / FLUIDS, VITAL SIGNS COMPROMISED. ACTION(S) TAKEN CHANGED OUT PUMP (ISOLATE AND SEND TO BIOENGINEERING DEPARTMENT), FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION / FLUID RINGERS IV RATE TKO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913479 ↗
• MalfunctionAug 27, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT EXACTLY AS IT OCCURRED: NURSE NOTICED THAT THE PATIENT'S IRINOTECAN HAD ITS LINE FILLING UP WITH AIR, AND SOLUTION WASN'T FLOWING FROM BAG. PHARMACIST LOOKED AT LINE, AND PHARMACY MADE A NEW BAG FOR THE PATIENT. TESTED THE BAG AFTERWARDS. THE BULB ON THE LINE WOULD NOT FILL WHEN ATTEMPTING TO BACK-PRIME THE LINE. NO SOLUTION WOULD FLOW THROUGH THE LINE. MADE SURE THAT IT WASN'T CLAMPED DOWN ANYWHERE ON THE LINE. IT DIDN'T SEEM TO HAVE PRESSURE IN THE BULB, ALMOST FELT DEFLATED. LINE IS DEFECTIVE IN SOME WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905547 ↗
• MalfunctionAug 24, 2025Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT EXACTLY AS IT OCCURRED: WHEN DRUG WAS BEING INFUSED THROUGH THE IV LINE, TO THE PATIENT, THE NURSE NOTICED A GIANT AIR BUBBLE IN THE LINE. UPON FURTHER INSPECTION THEY FOUND THAT THERE WAS A LEAK IN THE LINE AT THE POINT WHERE THE BUBBLE CATCHER ENDS. THE WHITE PLASTIC PIECE WAS BROKEN AND THERE WAS DRUG LEAKING. DURING THE DOUBLE POST CHECK OF THE IV BAG AND LINE THERE WAS NO LEAK OR ISSUE FOUND, BEFORE SENDING IT OUT TO THE NURSES. THE DRUG WAS REMADE AND SENT OUT TO THE PATIENT FOR A SECOND TIME WITH NO PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881629 ↗
• MalfunctionAug 24, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT EXACTLY AS IT OCCURRED: PT OXAL/LEUCO STARTED. PT ALERTED NURSE SOON AFTER THAT IT APPEARED TO BE LEAKING FLUID. PUMPS BOTH STOPPED AND LINE ASSESSED. LINE APPEARED TO HAVE CRACK NEAR CONNECTION POINT ON THE OXALPLATIN LINE. PT HAD BLANKETS ON AND DRUG APPEARED TO NOT HAVE SATURATED THROUGH THE BLANKETS AND ONTO THE PATIENT. MOVED PATIENT AND FAMILY TO ANOTHER CHAIR TO THE SIDE TO CLEAN AREA. AREA HAD SLIGHT BLOOD DROP FROM SUSPECTED TUBE CRACK NOT HOLDING PRESSURE TO PATIENT SIDE. PHARMACY ALERTED AND AREA CLEANED THOROUGHLY WITH 1 AND 2 STEP WIPES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881587 ↗
• MalfunctionAug 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT EXACTLY AS IT OCCURRED: PHARMACY TECHNICIAN WAS PREPARING FOR THE DAY PRIMING LINES FOR HER BAGS OF FLUID FOR COMPOUNDING AND NOTICED ONE OF THE LINES HAD A FOREIGN SUBSTANCE (BLACK IN COLOR - POSSIBLY INK OR GLUE) IN THE PRIMING CHAMBER OF THE BBRAUN INFUSOMAT SPACE PUMP LINE SHE WAS GOING TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881584 ↗
• MalfunctionAug 24, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT EXACTLY AS IT OCCURRED: 30 MINUTES AFTER STARTING CISPLATIN, PUMPED ALARMED "ACCUMULATED AIR", NURSE RESPONDED TO PUMP AND WAS ABLE TO CLEAR LINE AND BUBBLES AND ATTEMPTING TO RESTART INFUSION PUMP ALARMED "INVALID LINE". NURSE REMOVED LINE AND REPLACED LINE BACK IN PUMP, CODE CLEARED, INFUSION RESTARTED WITH CORRECT DOSING PER ORDER. CISPLATIN INFUSION ALARMED AT 60-MINUTE MARK, NURSE DOUBLE VERIFIED FLUID IN BAG RUNNING AT THE CORRECT RATE. NURSE PROGRAMMED PUMP TO COMPLETE THE REMAINING CISPLATIN VOLUME IN THE BAG, IT INFUSED OVER 30 MORE MINUTES. ALERTED PHARMACY OF PROLONGED INFUSION. PT REPORTS NO COMPLICATIONS, DOING WELL WITH NO ADVERSE EFFECTS. INFUSION COMPLETED, PT D/C STABLE, INFORMED TO CALL WITH ANY CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881583 ↗
• MalfunctionAug 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: PARTICULATE OR INK WAS OBSERVED INSIDE THE DRIP CHAMBER, RIGHT OUT OF THE PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881563 ↗