Alaris, SmartSite 10406194Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 0.2 Micron Filter, Smallbore Tubing, 3 Y-Sites 390 cm (154 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403234224), received between Sep 19, 2019 and Nov 27, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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
- Fluid/Blood Leak2
- Material Puncture/Hole1
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE FILTER WAS LEAKING 0.9% SODIUM CHLORIDE. ALTHOUGH REQUESTED, THERE HAS BEEN NO PATIENT IMPACT OUTCOME RESPONSE OR FURTHER EVENT INFORMATION MADE AVAILABLE TO DATE.
Patient problems: No Information
MAUDE report 9386878 ↗MalfunctionSep 19, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THE RN NOTICED A HOLE ON THE PUMP SEGMENT NEAR THE UPPER FITMENT OF THE IV TUBING THAT CAUSED A LEAK. IT IS UNKNOWN IF THIS EVENT OCCURRED DURING INFUSION OR PRIMING. THE CUSTOMER PROVIDED A PHOTO OF THE TUBING. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL PATIENT OR EVENT INFORMATION AVAILABLE.
Patient problems: No Information
MAUDE report 9087215 ↗
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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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