Infusomat® 363421Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 04046964294617), received between Aug 3, 2017 and Jun 18, 2026 — classified as 1 injury, 85 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (48 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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-2388-2024 · Root cause: Process control · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: END USER REPORTS AIR IN LINE DURING USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545395 ↗
• MalfunctionApr 2, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: TUBING WAS REPEATING AIR IN LINE ALERTS EVEN AFTER FLUSHING AND CHANGING PUMP. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764875 ↗
• MalfunctionApr 2, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: CONSTANT AIR IN LINE IDENTIFIED BY SET DESPITE FLUSHING AND CHANGING PUMP. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764873 ↗
• MalfunctionFeb 17, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MULTIPLE AIR IN LINE ERRORS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370555 ↗
• MalfunctionFeb 16, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MULTIPLE AIR IN LINE ISSUES REPORTED FROM THE SET AFTER TROUBLESHOOTING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349226 ↗
• MalfunctionJan 13, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: SET HAD MULTIPLE AIR IN LINE MEDICATION COULDN'T BE GIVEN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053624 ↗
• MalfunctionJan 12, 2026Device Misassembled During Manufacturing /Shipping

  AS REPORTED BY THE USER FACILITY: DURING PREPARATION THE SET WAS NOTED TO HAVE THE GREEN CLIP BACKWARDS SO COULDN'T LOAD TUBING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035716 ↗
• MalfunctionDec 10, 2025Device Alarm System; Device Alarm System

  AS REPORTED BY THE USER FACILITY: THE INFUSION WAS SET TO INFUSE FOR 60 MINUTES. NO ISSUES WITH THE START OF INFUSION, BUT IT BEGAN TO BEEP AIR-IN-LINE WITH 10 MINUTES WITHOUT ANY VISIBLE AIR BUBBLES. THE RN CIRCLE-PRIMED THE LINE TWICE AND CHANGED OUT THE IV PUMP. THE INFUSION EVENTUALLY FINISHED BUT THE INFUSION WENT LONGER THAN PLANNED BY 45 MINUTES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770310 ↗
• MalfunctionNov 26, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: INFUSOMAT LINE CLAIMED TO HAVE PULLED AIR INTO THE PUMP WHILE INFUSING A MEDICATION. THIS PARTICULAR MEDICATION IS A RESCUE DRUG GIVEN POST HIGH-DOSE CHEMOTHERAPY TO PREVENT HEMORRHAGIC CYSTITIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655862 ↗
• MalfunctionNov 12, 2025Air/Gas in Device; Air/Gas in Device

  REASON OF COMPLAINT: TUBING WAS FIRING AIR-IN-LINE AFTER TROUBLESHOOTING AND REPEATED ATTEMPTS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535111 ↗
• MalfunctionNov 11, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY CUSTOMER NOTES TUBING BROKE AT Y-SITE WHILE RUNNING LEVOPHED, SET WAS SITED TO BE ONLY 1 DAY OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526593 ↗
• MalfunctionAug 7, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE GREEN CLIP WAS PLACE ON THE WRONG SIDE OF THE TUBING. THE OTHER SET THEY COMPLAINED OF AIR IN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737012 ↗
• MalfunctionJun 23, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: "SUCKING IN A WHOLE BUNCH OF AIR". DETAILED INQUIRY DESCRIPTION: THE SECTION WHERE AIR WAS PULLING FROM THE PIECE JUST SNAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306552 ↗
• MalfunctionApr 30, 2025Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: PRODUCT PROBLEM: UNRESOLVABLE AIR-IN-LINE ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934136 ↗
• MalfunctionMar 31, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION ZOSYN MEDICATION ADMINISTERED QUICKLY. DETAILED INQUIRY DESCRIPTION PT RECEIVED ZOSYN AT 1100. 5 RIGHTS WERE PERFORMED AND IV PUMP WAS SET TO RUN FOR 30 MINUTES PER ORDER. TUBING WAS PRIMED PROPERLY AND CONNECTIONS WERE CHECKED AS PER PROTOCOL. ABOUT 5 MINUTES AFTER THIS I WAS CALLED TO BEDSIDE D/T THE IV PUMP BEEPING/ALARMING. THE ALARM WAS READING "AIR IN LINE". THE PUMP AND LINE WERE INSPECTING AND THERE WAS AIR IN THE LINE BUT HAD NOT REACHED THE PT. I THEN NOTICED THE ZOSYN MEDICATION WAS EMPTY EVEN THOUGH THE MEDICATION WAS SET TO RUN FOR 30 MINUTES. THE PUMP READ IT HAD 40 ML LEFT TO INFUSE. THE PT WAS DISCONNECTED FROM THAT LINE. THE PATIENT STATED SHE FELT FINE AND MD NOTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734056 ↗
• MalfunctionJan 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: POPPING NOISE AND CHEMO SPILLED INSIDE PUMP. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067117 ↗
• MalfunctionJan 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CHEMO SPILL AND BROKEN PUMP TUBING IN PUMP. DETAILED INQUIRY DESCRIPTION: CHEMOTHERAPY SPILL BECAUSE B. BRAUN IV TUBING BROKE INSIDE THE IV PUMP AFTER INFUSING FOR ONE HOUR. RN WROTE AN EER SAYING THERE WAS A "LARGE VACUUM POPPING NOISE FROM THE IV PUMP" AND WHEN SHE ASSESSED, SHE FOUND CHEMO LEAKING FROM THE PUMPS WITH BLOOD BACK FLOWING FROM PICC LINE. PRODUCT PRIMED BY PHARMACY SO LOT NUMBER NOT AVAILABLE AND SAMPLE DISCARDED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066987 ↗
• MalfunctionOct 21, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): AIR IN LINE ALARM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492193 ↗
• MalfunctionOct 11, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED, CUSTOMER BOUGHT NEW PUMPS, UPON IMPLEMENTING PUMPS THE NURSE REMOVED THE TUBING FROM CURRENT PUMPS AND PUT IN NEW PUMP. IMMEDIATE AIL ALARM. HAPPENED OVER AND OVER AGAIN WITH A FEW PUMPS. I AM SENDING IN 3 DIFF LOTS OF TUBE SETS. PLEASE CHECK ALL AND DETERMINE IF THIS IS A TUBING ISSUE. IT IS LIKELY THAT THEY WERE USING THE PUMP SETS ENDING IN 44 WHEN THIS ISSUE HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429085 ↗
• MalfunctionOct 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED, CUSTOMER BOUGHT NEW PUMPS, UPON IMPLEMENTING PUMPS THE NURSE REMOVED THE TUBING FROM CURRENT PUMPS AND PUT IN NEW PUMP. IMMEDIATE AIL ALARM. HAPPENED OVER AND OVER AGAIN WITH A FEW PUMPS. I AM SENDING IN 3 DIFF LOTS OF TUBE SETS. PLEASE CHECK ALL AND DETERMINE IF THIS IS A TUBING ISSUE. IT IS LIKELY THAT THEY WERE USING THE PUMP SETS ENDING IN 44 WHEN THIS ISSUE HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409477 ↗
• MalfunctionOct 9, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED, CUSTYOMER BOUGHT NEW PUMPS, UPON IMPLEMENTING PUMPS THE NURSE REMOVED THE TUBING FROM CURRENT PUMPS AND PUT IN NEW PUMP. IMMEDIATE AIL ALARM. HAPPENED OVER AND OVER AGAIN WITH A FEW PUMPS. I AM SENDING IN 3 DIFF LOTS OF TUBE SETS. PLEASE CHECK ALL AND DETERMINE IF THIS IS A TUBING ISSUE. IT IS LIKELY THAT THEY WERE USING THE PUMP SETS ENDING IN 44 WHEN THIS ISSUE HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409252 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY USER FACILITY, THE TUBING SEPARATED NEAR THE VALVE AFTER THE INFUSION WAS COMPLETED AND DISCONNECTED FROM THE VETERAN. SPECIFICALLY, IT WAS NOTED THAT THE DISTAL PORTION OF THE TUBING AT THE LOWER LURE ACCESS AND ANTI-SIPHON VALVE HAD SEPARATED. THE SEPARATION OCCURRED AFTER THE INFUSION HAD COMPLETED AND WHEN IT WAS DISCONNECTED FROM THE VETERAN. THE NURSE STATED THERE WAS NO DIFFICULTY IN DISCONNECTING THE LINE, WITH NO FORCEFUL ACTION IN DISCONNECTING THE LINE FROM THE VETERAN. AS SHE PUT IT, "IT CAUGHT ME OFF GUARD AND WAS COMPLETELY UNEXPECTED".

  Patient problems: Chemical Exposure

  MAUDE report 20398140 ↗
• MalfunctionJun 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION 1)PARTICULATE MATTER IN DRIP CHAMBER. 2) SECONDARY BACKING UP INTO PRIMARY. DETAILED INQUIRY DESCRIPTION 1) RN WHEN TO PRIME TUBING AND SAW BROWN DOTS IN DRIP CHAMBER. SEE PICTURES. 2) SECONDARY SET BACKING UP INTO PRIMARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605139 ↗
• MalfunctionJun 25, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIR IN LINE. DETAILED INQUIRY: DESCRIPTION AIR IN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605103 ↗
• MalfunctionJun 19, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: "I AM CALLING FROM (B)(6) HOSPITAL IN (B)(6). I WAS JUST CALLING AND LEAVING A MESSAGE ABOUT A PIECE OF ABOUT A TUBING, A PRIMARY TUBING THAT JUST MALFUNCTIONED AND BOLUS AN ENTIRE BAG OF MEDICINE INTO A PATIENT. AND SO, WE KNOW IT WASN'T THE PUMP BECAUSE AFTER THAT STARTED HAPPENING, THEY, THEY CHANGED OUT THE TUBING TO NEW TUBING AND THE PUMP WAS WORKING FINE AFTER THAT, THE LOT NUMBER OF THIS TUBING IS 006-193-0315. AND I JUST WANTED TO TOUCH BASE WITH SOMEBODY TO KIND OF FIGURE OUT LIKE NEXT STEPS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570379 ↗