Infusomat® 490038Recalls & reported problems
B. Braun Medical Inc. · 60 drops/mL, priming volume: 11mL, length: 129in · 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 04046964185946), received between Jan 4, 2024 and Oct 11, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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
- Leak/Splash2
- Device Alarm System1
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.
MalfunctionOct 11, 2024Leak/Splash; Leak/Splash
AS REPORTED, THE BLUE-GREEN VENT COVER FELL OFF THE VENT ON THE SPIKE. THIS MADE SOME OF THE CHEMO MEDICATION TO COME OUT OF THE VENT. THE NURSE QUICKLY PUT THE VENT COVER BACK IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427409 ↗MalfunctionJan 29, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: LEAKING AT THE PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: LEAKING AT THE PUMP SEGMENT DURING PRIMING BEFORE THE ADMINISTRATION OF CHEMO. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18595672 ↗MalfunctionJan 4, 2024Device Alarm System; Device Alarm System
AS REPORTED BY THE USER FACILITY: INFUSOMAT SPACE PUMP IV SET PORTLESS TUBING/EPIDURAL ADMIN TUBING SET ALARMS AND DOES NOT ALLOW USER TO INFUSE CRITICAL MED (IE: FENTANYL). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443560 ↗
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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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