Infusomat® 363219Recalls & reported problems
B. Braun Medical Inc. · Priming volume: 41mL, length: 129in, ULTRASITE® · Class 2
All models of Infusomat (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964294372), received between Nov 23, 2016 and Nov 23, 2016 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).
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.
Most reported problems
Device problems
- Device Operates Differently Than Expected3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 3: BLOOD LEAKING AROUND THE BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124596 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 2. BLOOD LEAKING AROUND THE BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124591 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 1: BLOOD LEAKING AROUND THE BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124589 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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
- 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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