Space Infusomat 490102HRecalls & reported problems
B. Braun Medical Inc. · PUMP SET,15DR,2 CARESITE,100PERCENT INSP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046961016816), received between May 21, 2026 and Sep 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (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.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device3
- Free or Unrestricted Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927924 ↗MalfunctionSep 25, 2026Air/Gas in Device
As reported by the user facility:Persistent air bubbles after starting drip. Unable to clear alarm. Line and pump were changed. No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896569 ↗MalfunctionMay 24, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: IV TUBING ALARMING FOR MULTIPLE AIR BUBBLE ALARM. LOTS OF SMALL BUBBLES FOUND IN TUBING. REPORTED AIR BUBBLE ALARM FOR PREVIOUS DAY SHIFT. NEW TUBING CHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266964 ↗MalfunctionMay 21, 2026Free or Unrestricted Flow
AS REPORTED BY THE USER FACILITY: SECONDARY MEDICATION INFUSED WITHIN 1 MINUTE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244146 ↗
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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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