Alaris, SmartSite 2401-0500Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Y-Site 276 cm (109 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 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 07613203012515), received between Aug 8, 2018 and Aug 22, 2018 — classified as 2 malfunctions.
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
- Material Separation1
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.
MalfunctionAug 22, 2018Fluid/Blood Leak; Fluid/Blood Leak
RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA, WHICH STATES ¿NURSING CHANGED LIPID LINE INFUSING VIA A UMBILICAL VENOUS LINE AND NOTED LIPIDS LEAKING OUT OF IV CHANNEL. LIPID IV LINE NOTED TO BE LEADING AT A CONNECTOR SITE. IV TUBING CHANGED AFTER NEW BAG OF LIPIDS SENT BY PHARMACY, CAUSING A DELAY IN LIPID ADMINISTRATION. THERE WAS NO HARM TO THE PATIENT". AN INCOMPLETE DATE OF EVENT OF (B)(6) 2018 WAS PROVIDED. THE CUSTOMER LATER REPORTS THAT THE EVENT OCCURRED ON (B)(6) 2018 AND THAT THERE WAS A DELAY IN LIPID ADMINISTRATION, BUT THERE WAS NO RESULTING HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7807270 ↗MalfunctionAug 8, 2018Material Separation; Material Separation
THE CUSTOMER REPORTED THAT WHEN FLUSHING TUBING FOR A VANOFER INFUSION, THE TUBING SEPARATED AT THE AREA THAT GOES THROUGH THE SENSOR. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7763881 ↗
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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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