Infusomat® 363220Recalls & reported problems
B. Braun Medical Inc. · 15 drops/mL, priming volume: 22mL, length: 120in, ULTRASITE® · Class 2
All models of Infusomat (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964294396), received between Nov 23, 2016 and Nov 23, 2016 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (6 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 Expected6
Patient problems
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 6 most recent of 6 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 6: LEAKING AT BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124520 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 5: LEAKING AT BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124509 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 2: LEAKING AT BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124500 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 4: LEAKING AT BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124498 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 3. LEAKING AT BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124495 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 1. LEAKING AT BLOOD FILTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124488 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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
- 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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