Alaris, SmartSite 11404930Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 3 Y-Sites 296 cm (117 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613203021197), received between Apr 23, 2019 and Nov 4, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (1 report).
2 FDA recall records name this device's identifier, 1 still open.
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.
Recalls naming this device
- Aug 19, 2026Class IOpen, Classified
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗
- May 6, 2019Class ITerminated
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Deformation1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2019Stretched; Stretched
IT WAS REPORTED THAT THE TUBING BALLOONED IN THE PUMP SEGMENT. MEDICATION INFUSING AT THE TIME WAS AN ANTIBIOTIC. THERE WERE NO ISSUES AFTER THE TUBING WAS REPLACED. RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA WHICH STATES, ¿TUBING BUBBLED OUT DURING ADMINISTRATION. TUBING WAS ON A PUMP WITH ANTIBIOTIC."
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9275554 ↗MalfunctionApr 23, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TUBING SET DEVELOPED A BALLOON IN THE SILICONE SEGMENT DURING A MEROPENEM INFUSION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540455 ↗
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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 · each recall links to the FDA recall notice
- 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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