Alaris, SmartSite 82105ERecalls & reported problems
BD Switzerland Sàrl · Alaris SmartSite Add-On Burette Set · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613203009638), received between Dec 9, 2024 and Dec 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Infusion or Flow Problem; Infusion or Flow Problem
RN STATED THAT WHEN ADMINISTERING FLUIDS USING ALARIS SYSTEM AND A BURETTE SET UP, THAT THE CONTENT ISN'T EMPTYING COMPLETELY. FOR EXAMPLE, 100MLS OF VOLUME RUNNING AT 100MLS/HR, THE FLUID IN THE BURETTE AFTER ONE HOUR LEAVES AROUND 10-15MLS (INSTEAD OF BEING COMPLETED) AND THE NURSE HAS TO COME BACK TO ENSURE THE REMAINDER OF THE FLUID HAS GONE THROUGH. THE NURSE STATES, THIS IS TIME CONSUMING, RESULTS IN UNWANTED NUISANCE ALARMS AND CAN BE HIGH RISK WITH CRITICAL DRUGS. (B)(6) HAS NOTIFIED, (B)(4) WHO IS CLINICAL PRODUCTS FOR THE DEPARTMENT, AND NOTIFIED THE NUM OF ICU. THIS OCCURRENCE HAS HAPPENED ON MULTIPLE OCCASIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878110 ↗
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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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