Alaris, SmartSite 11118122Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Burette Set, 0.2 Micron Filter, Port (Burette) 3 Y-Sites 330 cm (130 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 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 10885403234675), received between Oct 3, 2019 and Oct 3, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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 18, 2026.
Most reported problems
Device problems
- Material Separation3
Patient problems
- No Information3
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2019Material Separation; Material Separation
THE CUSTOMER LATER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Information; No Patient Involvement
MAUDE report 9151748 ↗MalfunctionOct 3, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THERE HAVE BEEN MULTIPLE TUBING SETS FOUND TO BE SEPARATED AT VARIOUS LOCATIONS.
Patient problems: No Information; No Patient Involvement
MAUDE report 9151747 ↗MalfunctionOct 3, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THERE HAVE BEEN MULTIPLE TUBING SETS FOUND TO BE SEPARATED AT VARIOUS LOCATIONS.
Patient problems: No Information; No Patient Involvement
MAUDE report 9151683 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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