Alaris, SmartSite 10031773Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 2 Back Check Valves, 4 Y-Sites 355 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403220920), received between Aug 26, 2019 and Jan 13, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
- Fluid/Blood Leak1
- Incomplete or Missing Packaging1
- Loose or Intermittent Connection1
- Separation Failure1
Patient problems
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2020Separation Failure; Separation Failure
IT WAS REPORTED THAT ANESTHESIA REPORTED THE ISSUE THE TUBING IS COMING APART. TUBING CAME APART IN THE OR SHORTLY AFTER PUTTING THE PATIENT TO SLEEP. ONCE TUBING CAME APART THE BLOOD FROM IV STARTED BACKING UP AND UNDID UP GETTING ALL OVER THE LEG OF THE ANESTHESIA PROVIDER. THERE WAS NO IMPACT TO THE ANESTHESIA PROVIDER. IT WAS REPORTED THAT PATIENT CARE WAS NOT DELAYED AND IT DID NOT CONTRIBUTE TO, OR RESULT IN SERIOUS ADVERSE IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9583555 ↗MalfunctionNov 15, 2019Incomplete or Missing Packaging; Incomplete or Missing Packaging
IT WAS REPORTED THAT AFTER PRIMING THE SET WITH LACTATED RINGER'S, THE RN ATTACHED THE TUBING TO THE PATIENT AND NOTICED THAT THE ROLLER CLAMP WAS UPSIDE DOWN. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM, HOWEVER; THERE WAS INCONVENIENCE AND WASTE OF SWITCHING THE TUBING AND BAG OF LACTATED RINGER'S AFTER THE IV START.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9331395 ↗MalfunctionAug 26, 2019Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT THE SET IS LOOSELY CONNECTED AND NOT SECURED BY THE LUER LOCKS WHICH RESULTED IN THE IV BEING PULLED OUT. IV SOLUTION LEAKED ON THE FLOOR, WHICH RESULTED IN THE PATIENT NEEDING A NEW IV AND DELAYING THEIR PROCEDURE. IT'S UNKNOWN IF THE FLUID THAT LEAKED WAS NORMAL SALINE OR LACTATED RINGERS. THIS WAS FURTHER DESCRIBED AS, "...THE CONNECTION POINT FROM THE DRIP CHAMBER DOWN TO THE TUBING HAD AN ADDED CONNECTOR THAT WAS NEW TO WHAT THEY USUALLY USE AND THAT IT WAS LOOSENED UPON OPENING AND STAFF WAS NOT AWARE OF THIS."
Patient problems: No Information
MAUDE report 8933339 ↗
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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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