Alaris, SmartSite 10013889Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Low Sorbing Tubing, Back Check Valve, 3 Y-Sites 325 cm (138 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 10885403232282), received between Jul 3, 2019 and Jul 3, 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
- Material Separation1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM CDRH WHICH STATES, ¿BD ALARIS PUMP INFUSION SET, LOW SORBING TUBING: LOT NUMBER: 17105562. EXPIRATION 10/05/2020, REFERENCE NUMBER (B)(4). TUBING CAME APART AT PUMPING SEGMENT AND AVASTIN WAS SPILLED IN THE HEM/ONC PATIENT ROOM".
Patient problems: No Information
MAUDE report 8757932 ↗
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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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