Infusomat® 470119Recalls & reported problems
B. Braun Medical Inc. · 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE® · Class 2
All models of Infusomat (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964298714), received between May 15, 2025 and Sep 12, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (3 reports).
1 FDA recall record name this device's identifier, 1 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Air/Gas in Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: PUMP INFUSING AMIODARONE ALARMED ACCUMULATED AIR EXCEEDS LIMIT". AMIODARONE INFUSION HAD TO BE STOPPED FOR 3 MINUTES, AND TUBING REQUIRED PRIMING WITH 5 ML FOUR TIMES (TOTAL 20 ML) IN ORDER TO FULLY CLEAR AIR AND RESUME INFUSION. THIS RESULTING IN WASTING 20 ML OF THE MEDICATION AND DELAY IN PATIENT TREATMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037868 ↗MalfunctionJul 15, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: AIR/GAS IN DEVICE. TUBING ONLY 24 HOURS OLD. SOLUTION DILANTIN AT ROOM TEMPERATURE. MULTIPLE ATTEMPTS TO CLEAR BUBBLE ALARMS. PRIME FLUSH, FLICKED BUBBLES, CHANGED MACHINES. INFUSED BY GRAVITY WITH ROLLER CLAMP TO ADJUST INFUSION RATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22508995 ↗MalfunctionMay 15, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: OTHER DETAILS: PUMP ALARMING DOWNSTREAM OCCLUSION ON TPN- AMD SOLUTION. NO CLAMPS OR KINKS NOTED IN TUBING OR PICC LINE, PRESSURE SENSOR ALREADY SET TO 9. PICC LINE FLUSHED WITH NO RESISTANCE, TRIED INTERVENTIONS INDIVIDUALLY WITHOUT RESOLVING 1) PUMP CHANGED 2) PICC CAP CHANGED AND PICC FLUSHED 3) Y SITE CONNECTOR CHANGED PICC FLUSHED 4) PATIENT REPOSITIONING. THEN TRIED CHANGING IV TUBING. ONCE CHANGED PRESSURE SENSOR BAR WENT FROM FULL TO EMPTY, AND NO FURTHER DOWNSTREAM OCCLUSION ALARMS OCCURRED. INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS, RISK FOR INFECTION / INTRODUCTION OF CONTAMINANTS, OTHER. POTENTIAL FOR DROP IN BLOOD SUGAR, OR OCCLUSION OF PICC LINE WHICH IS PATIENT'S ONLY SOURCE OF NUTRITION. 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: TPN- AMD SOLUTION. IV RATE: 64 ML/HR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22025825 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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