Alaris, SmartSite 2424-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 4 Y-Sites, 315 cm (124 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 10885403222177), received between Jun 11, 2024 and Aug 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Backflow” (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.
Reports received per month
Most reported problems
Device problems
- Backflow1
- Connection Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2026Connection Problem
It was reported that BD alaris smartsite pump infusion set was separated.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that the RN was attaching a PhaSeal Optima Connector to the medial port on the Pump Infusion set (lot # 26055676) and the tubing came apart at the connection point of the tubing to the medial port site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266622 ↗MalfunctionJan 21, 2026Backflow
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CEFEPIME WAS PROGRAMMED TO RUN AS A SECONDARY IV BAG THE MEDICATION WAS BACKFILLED INTO THE 500 ML BAG OF NORMED SALINE @ FAST RATE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WAS THERE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THIS EVENT? THE PATIENT DID NOT RECEIVE THE ANTIBIOTIC. A KNEW BAG HAD TO BE ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24138125 ↗MalfunctionJun 11, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: I WANTED TO SHARE AN ADDITIONAL SITUATION THAT OCCURRED WITH A CHEMOTHERAPY PRODUCT BEING HUNG ON A PATIENT TODAY. DESPITE THE TUBING BEING INSPECTED AND SECURED BY THE VERIFYING PHARMACIST, THE SAME LUER PIECE CAME APART WHILE THE NURSE WAS ATTACHING THE MEDICATION TO THE PATIENT. THE PATIENT WAS NOT HARMED BUT THERE WAS CHEMO SPILLAGE IN THE INFUSION CENTER AND ON THE INFUSION NURSE, IN ADDITION TO THE MEDICATION HAVING TO BE RE-COMPOUNDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510701 ↗
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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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