Alaris, SmartSite 10014855ARecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 2 Y-Sites 294 cm (116 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 10885403232619), received between Oct 28, 2019 and Oct 28, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
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.
MalfunctionOct 28, 2019Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "INFUSION PUMP ALARM NOTED AS AIR IN LINE, TAKEN OUT OF PUMP AN NOTED LEAKING, NOTED HOLE BELOW FIRST BLUE PART OF TUBING." AN INCOMPLETE EVENT DATE OF (B)(6) 2019 WAS PROVIDED. THE EVENT OCCURRED IN PEDIATRIC ICU (PICU). IT WAS FURTHER CONFIRMED DURING FOLLOW-UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9246787 ↗
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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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