Alaris, SmartSite 11059729Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 4-Way Stopcock, 4 Y-Sites 329 cm (130 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403232497), received between Nov 9, 2018 and Dec 31, 2019 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (2 reports).
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.
Most reported problems
Device problems
- Disconnection2
- Fluid/Blood Leak2
- Device Difficult to Setup or Prepare1
- Excess Flow or Over-Infusion1
- Failure to Deliver1
- Insufficient Flow or Under Infusion1
Patient problems
- No Information2
- Inadequate Pain Relief1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 31, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE MEDICATION WAS FLOWING FASTER THAN IT SHOULD INTO THE PATIENT'S IV TUBING. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT RECEIVED.
Patient problems: No Information
MAUDE report 9536266 ↗MalfunctionOct 22, 2019Device Difficult to Setup or Prepare; Insufficient Flow or Under Infusion; Failure to Deliver; Device Difficult to Setup or Prepare; Insufficient Flow or Under Infusion; Failure to Deliver
IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ASSEMBLING THE ANESTHESIA SET DUE TO THE COMPONENTS WERE INCOMPATIBLE; "THE MALE LUER CONNECTOR AT THE END OF AN EXTENSION TUBE DID NOT OPEN THE VALVE ON THE FEMALE Y-PORT". THE CUSTOMER STATED THAT THE TRAUMA PATIENT HAD A DELAY IN CRITICAL MEDICATIONS DUE TO THE ISSUE HOWEVER THE STAFF WAS ABLE TO CONNECT THE SET AFTER FIXING THE ISSUE . IT WAS LATER REPORTED TURNS OUT TO BE A COMPATIBILITY ISSUE WITH ICU MEDICAL¿S MALE LUER LOCK BEING UNABLE TO ENGAGE THE SMART SITE Y-PORT ON BD¿S TUBING SETS.THE PHYSICIAN WAS ABLE TO QUICKLY DETERMINE THE INCOMPATIBILITY AND CHANGE THE METHOD OF DELIVERY.
Patient problems: No Information
MAUDE report 9221375 ↗InjuryNov 15, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED FROM THE STOPCOCK AND LEAKED WHILE ANESTHESIA WAS INDUCING A PATIENT. THIS RESULTED IN ADMINISTERING MORE SEDATION MEDICATION TO THE PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: Inadequate Pain Relief
MAUDE report 8076484 ↗MalfunctionNov 9, 2018Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED FROM THE STOP COCK CAUSING THE PATIENT TO BLEED BACK UP INTO THE LINE AND ONTO THE FLOOR DURING AN OPERATING ROOM CASE. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8057377 ↗
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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
- 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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