Alaris, SmartSite 2443-0600Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, Port (Burette), 3 Y-Sites, 333 cm (131 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403235061), received between Aug 8, 2018 and Sep 17, 2018 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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
- Fluid/Blood Leak4
- Crack1
- Noise, Audible1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2018Crack; Noise, Audible
THE CUSTOMER REPORTED THAT THE DEVICE ALARMED FOR NEOI (NEAR END OF INFUSION), AND THE TPN BURETTE WAS EMPTY WITH THE CLAMP CLOSED. THE USER OPENED THE CLAMP AND SLIGHTLY PRESSED THE BURETTE TO FILL IT; HOWEVER, THE BURETTE CRACKED WITH A LOUD POPPING SOUND. THE USER IMMEDIATELY CLAMPED AND STOPPED THE INFUSION, AND REMOVED THE TUBING. A CHANGE IN SOLUTION OF D5W/0.9% NACL WITH KCL WAS ORDERED AND HUNG, AND PHARMACY WAS NOTIFIED FOR A NEW TPN REPLACEMENT BAG. A SEPARATE INFUSION OF LIPIDS AT AN UNSPECIFIED RATE REMAINED INFUSING. IT WAS REPORTED THE LAST TUBING CHANGE WAS (B)(6) AND IT WAS DUE TO BE CHANGED ON (B)(6). THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7882125 ↗MalfunctionAug 8, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATED THAT DURING INFUSION THE 60 GTT BURETTE WITH THE 0.2 MICRON FILTER, IT LEAKS AT THE FILTER. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7763666 ↗MalfunctionAug 8, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATED THAT DURING INFUSION THE 60 GTT BURETTE WITH THE 0.2 MICRON FILTER, IT LEAKS AT THE FILTER. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7763480 ↗MalfunctionAug 8, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATED THAT DURING INFUSION THE 60 GTT BURETTE WITH THE 0.2 MICRON FILTER, IT LEAKS AT THE FILTER. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7763406 ↗MalfunctionAug 8, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATED THAT DURING INFUSION THE 60 GTT BURETTE WITH THE 0.2 MICRON FILTER, IT LEAKS AT THE FILTER. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7763403 ↗
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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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