Alaris, SmartSite 10137405Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Low Sorbing Tubing, Back Check Valve, 3 Y-Sites 303 cm (119 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403232503), received between Nov 7, 2018 and Jan 4, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Crack1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A TUBING LEAK. THERE WAS NO REPORT OF HARM. THE SPECIFIC EVENT DATE WAS NOT PROVIDED HOWEVER IT OCCURRED WITH THE LAST COUPLE OF YEARS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8219911 ↗MalfunctionNov 7, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED TUBING CRACKED AND LEAKED WHILE INFUSING CHEMO. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8048802 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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