Infusomat® 362033Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964837821), received between Mar 14, 2024 and Jul 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (3 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-2379-2024 · 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): BACK TO BACK SHIFTS AS PT STARTED TPN @ 1800 AND INFUSED OVERNIGHT, THERE WAS CONSISTENT AIR BUBBLES AND CONSISTENT ALARMS, TROUBLE SHOOTING TECHNIQUES ATTEMPTED, DESPITE PRIMING ON THE PUMP STILL HAD NUMEROUS AIR BUBBLES, AS WELL AS ATTEMPTS TO CHANGE THE TUBING NUMEROUS TIMES AND CHANGING OUT THE PUMP. ALARM EVENTS AIR IN LINE - NOT VISIBLE AND UNRESOLVED. DELAY IN PT RECEIVING ORDERED AMOUNT OF LIPIDS FOR PARENTERAL NUTRITION. IMPACT TO PATIENT: DELAY IN TREATMENT, EMOTIONAL DISTRESS, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, RISK FOR INFECTION / INTRODUCTION OF CONTAMINANTS, UNDER DOSING OF ORDERED MEDICATION / FLUIDS. 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, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION / FLUID LIPIDS IV RATE APPROX 12ML.

  Patient problems: Distress

  MAUDE report 22382737 ↗
• MalfunctionJun 24, 2025Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: LIPID INFUSION CONTINUED TO RING AIR IN LINE". WRITER USED A 10CC SYRINGE CONNECTED IT TO THE SINGLE PORT AND ATTEMPTED TO PRIME 10MLS OUT TO OBTAIN THE AIR BUBBLE. NO AIR BUBBLE WAS VISUALIZED IN THE LINE. THE PUMP CONTINUED TO RING "AIR IN LINE" AFTER THIS. BEDSIDE NURSE CHANGED OUT B. BRAUN PUMP (USED SAME LIPIDS TUBING). PUMP STILL CONTINUED TO RING "AIR IN LINE". BEDSIDE NURSE THEN CHANGED THE LIPIDS TUBING WHICH SEEMED TO BE EFFECTIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318323 ↗
• MalfunctionMar 14, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIR IN LINE ALARM WITH TPN TUBING SET. DETAILED INQUIRY DESCRIPTION: "TPN TUBING IS ALARMING "AIR IN LINE" OVER AND OVER AND OVER.... IN SPITE OF MULTIPLE ATTEMPTS BY SEVERAL NURSES TO CLEAR THE LINE. WE JUST FIXED THE TRAVASOL LINE, THEN THE LIPID LINE ALARMED. AGAIN. FINALLY REPLACED THE TUBING." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904248 ↗