Alaris, SmartSite 2410-0500Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 2 Y-Sites 290 cm (114 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613203012492), received between Oct 4, 2018 and Nov 23, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Backflow” (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
- Sep 11, 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-0035-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Backflow2
- Complete Blockage2
- Fluid/Blood Leak1
- Free or Unrestricted Flow1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2021Backflow; Complete Blockage; Backflow; Complete Blockage
IT WAS REPORTED THAT A BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD FLOW ISSUES AND BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE PRIMARY AND SECONDARY TUBING, THE SECONDARY FLUID BACK UP INTO THE PRIMARY CONTAINER. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12865562 ↗MalfunctionJan 28, 2021Complete Blockage; Free or Unrestricted Flow; Complete Blockage; Free or Unrestricted Flow
IT WAS REPORTED THAT AS LVP 20D DEHP 2SS HAD A BACK FLOW ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT THERE WAS A BACK FLOW ISSUE WHERE SECONDARY MEDICATION WAS FOUND IN THE PRIMARY MEDICATION BAG.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11243462 ↗MalfunctionMay 29, 2019Backflow; Backflow
IT WAS REPORTED THAT WHEN SECONDARY TUBING WAS ATTACHED, THE CONTENTS OF THE SECONDARY BAG IMMEDIATELY ENTERED THE PRIMARY BAG. THERE WAS NO PATIENT HARM REPORTED. THE USER OBSERVED THE ISSUE, IDENTIFIED AND ADDRESSED THE PROBLEM DIRECTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8649470 ↗MalfunctionOct 4, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE REPORT SUGGESTS THAT A LEAK WAS IDENTIFIED FROM THE OPENED AIRVENT DURING A CYCLOPHOSPHAMIDE INFUSION FROM A COLLAPSIBLE BAG. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7934965 ↗
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