Alaris, SmartSite 2451-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 3 Back Check Valves, 5 Y-Sites, 340 cm (134 in) · 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 10885403220432), received between Sep 26, 2018 and Sep 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2018Break; Break
THE CUSTOMER REPORTED THAT A MAINLINE OF LACTATED RINGER WAS PROGRAMMED AT 20/HR. DURING AN ENDOSCOPY PROCEDURE. THE PATIENT RECEIVED IV SEDATION OF MIDAZOLAM AND FENTANYL AND THEN WAS GIVEN A MANUAL FLUSH 10ML NORMAL SALINE. APPROXIMATELY 30 MIN LATER THE USER NOTICED SET "BLEW APART¿ AT AN UNSPECIFIED LOCATION. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7910729 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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