Alaris, SmartSite C24111ERecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 3 Y-Sites 306 cm (121 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 10885403220937), received between May 14, 2019 and May 14, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Obstruction of Flow1
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.
MalfunctionMay 14, 2019Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation
IT WAS REPORTED THAT THE NURSE PRIMED THE TUBING WITH AN IRON SUCROSE 300MG IN NORMAL SALINE 250ML, PLACED IT INTO THE PUMP MODULE AND IT ALARMED OCCLUSION IMMEDIATELY. THE NURSE OPENED THE DOOR AND NOTICED A BULGE IN THE PUMPING SEGMENT. THE NURSE STATED THAT ALL CLAMPS WERE OPEN AND THERE WERE NO IV FLUSHES PERFORMED. THE TUBING WAS REPLACED AND MEDICATION INFUSED ON THE EXISTING PUMP MODULE WITH NO FURTHER PROBLEMS. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM, DELAY IN CARE OR ADDITIONAL TREATMENT REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8610480 ↗
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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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