Alaris, SmartSite 11419365Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 Y-Sites 403 cm (159 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403234736), received between Dec 13, 2023 and Dec 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).
2 FDA recall records name this device's identifier, 2 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.
Reports received per month
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 ↗
- Jul 8, 2025Class IOpen, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Z-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Excess Flow or Over-Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 11419365, BATCH NUMBER#: 23075082. IT WAS REPORTED BY CUSTOMER THAT IN THE BLDG D R&D LAB, AN INFUSION WITH AN ALARIS SYSTEM SET INCORPORATED WITH A DISTAL MANIFOLD (MODEL: 11419365), RESULTED IN AN OVER INFUSION AS THE INFUSION WAS INITIATED ON 1 OUT OF 3 SETS TESTED. THE INFUSION WAS PROGRAMMED TO RUN AT 0.1 ML/HR FOR 96 HOURS AS STATED IN TEST PROTOCOL (B)(4). VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. IN THE BLDG D R&D LAB, AN INFUSION WITH AN ALARIS SYSTEM SET INCORPORATED WITH A DISTAL MANIFOLD (MODEL: 11419365), RESULTED IN AN OVER INFUSION AS THE INFUSION WAS INITIATED ON 1 OUT OF 3 SETS TESTED. THE INFUSION WAS PROGRAMMED TO RUN AT 0.1 ML/HR FOR 96 HOURS AS STATED IN TEST PROTOCOL (B)(4). DATE OF EVENT: 25OCT2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18322600 ↗
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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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