Alaris, SmartSite 10015645Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 2 Y-Sites 295 cm (116 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403227967), received between Sep 12, 2019 and Sep 16, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
1 FDA recall record 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 ↗
Most reported problems
Device problems
- Fluid/Blood Leak2
- Material Puncture/Hole2
- Break1
- Material Separation1
Patient problems
- No Information3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT A NEW IV TUBING STARTED LEAKING WHEN SET-UP ON IV INFUSION PUMP TO INFUSE 0.9% NORMAL SALINE AT 5 ML/HR. THE LEAK WAS NOTED AT THE PUMP SEGMENT OF THE TUBING RIGHT AROUND THE UPPER FITMENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9071033 ↗MalfunctionSep 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING CHANGE OF IV TUBING, THE RN WAS PRIMING TPN TO STRING NEW SETS AND NOTED THAT THE TPN WAS LEAKING AT THE FILTER SITE. THIS WAS NOTICED BEFORE THE TUBINGS WERE ATTACHED TO THE PATENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9033279 ↗MalfunctionSep 12, 2019Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT TUBING HAS A HOLE IN THE PUMP SEGMENT.
Patient problems: No Information
MAUDE report 9014666 ↗MalfunctionSep 12, 2019Break; Break
IT WAS REPORTED THAT THE TUBING IS FALLING APART.
Patient problems: No Information
MAUDE report 9014657 ↗MalfunctionSep 12, 2019Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT TUBING HAS A HOLE IN THE PUMP SEGMENT.
Patient problems: No Information
MAUDE report 9014655 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page