Infusomat® 363423Recalls & reported problems
B. Braun Medical Inc. · 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE® · Class 2
All models of Infusomat (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964294655), received between Nov 30, 2016 and May 6, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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-2390-2024 · Root cause: Process control · Recall details · FDA record ↗
- 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
- Contamination /Decontamination Problem4
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: FOREIGN PLASTIC ITEM INSIDE THE IV TUBING JUST BEFORE THE FILTER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25104565 ↗MalfunctionMar 25, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT LOOKS LIKE A PLASTIC PIECE DISLODGED AND OCCLUDED THE DISTAL PART OF TUBING PROXIMAL TO LAST BACKCHECK VALVE. TUBING WAS ALREADY PRIMED AND INFUSING. WHEN TRANSFERRED FROM OR TO THE UNIT, DOWNSTREAM OCCLUSION ON PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688147 ↗MalfunctionMay 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "PRESENCE OF GLUE FROM THE ANTI-REFLUX VALVE AT THE PROXIMAL SITE: OCCLUSION OF THE TUBING, THE ENTIRE BATCH IS DEFECTIVE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059754 ↗MalfunctionDec 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WHILE STAFF WAS ATTEMPTING TO PRIME THE TUBING, A WHITE HARD PIECE WAS FOUND IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11010890 ↗MalfunctionNov 30, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: FINDING AIR BUBBLES IN LINE, NEAR THE SILICONE PUMP SEGMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6134563 ↗
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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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