Alaris, SmartSite 10015294Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 2 Back Check Valves, 3 Y-Sites 356 cm (140 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
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403227981), received between Nov 11, 2016 and Apr 1, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Chemical Spillage” (1 report).
1 FDA recall record name this device's identifier.
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
- 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
- Chemical Spillage1
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT TUBING CRACKED AND LEAKED. WHILE GATHERING TUBING TO PRIME, THE NURSE PUNCTURED A 250ML BAG OF VANCOMYCIN AND HAD CONTENTS OF THE BAG LEAK ON THE FLOOR. THE ISSUE APPEARS TO BE THE BLUE HUB THAT IS PLACED IN PUMP HAD A CRACK AND THAT IS THE SITE THAT THE SOLUTION LEAKED FROM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9913447 ↗MalfunctionNov 11, 2016Chemical Spillage
THE SEAL CONNECTING TO THE SPIROS FROM THE TUBING WAS DEFECTIVE SO CHEMO LEAKED ON THE BED AND ON THE PATIENT. THIS IS A SMARTSITE INFUSION SET USED IN AN ALARIS PUMP MODULE THAT WOULD NOT LOCK ONTO THE SPIROS - ACTUALLY THERE ARE TWO SETS OF TUBING THIS HAPPENED WITH - CAUSING LEAKAGE OF CHEMO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6102189 ↗
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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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