Alaris, SmartSite 11287205Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 4 Y-Sites 325 cm (128 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613203019064), received between Jan 28, 2019 and Mar 3, 2020 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Material Separation” (7 reports).
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 Separation7
- Failure to Prime1
Patient problems
- No Patient Involvement7
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING A BD CLINICAL PRACTICE SITE VISIT, IT WAS REPORTED THAT THE TUBING SETS HAD SEPARATED BELOW THE SAFETY CLAMP AS WELL AS AT THE UPPER FITMENT, UPON LOADING THE SET INTO THE PUMP. THE EVENT OCCURRED IN INPATIENT PEDIATRIC UNITS AND PEDIATRIC INTENSIVE CARE UNITS (PICU), PRIOR TO ATTACHING THE SETS TO THE PATIENTS.
Patient problems: No Patient Involvement
MAUDE report 9782500 ↗MalfunctionMar 3, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING A BD CLINICAL PRACTICE SITE VISIT, IT WAS REPORTED THAT THE TUBING SETS HAD SEPARATED BELOW THE SAFETY CLAMP AS WELL AS AT THE UPPER FITMENT, UPON LOADING THE SET INTO THE PUMP. THE EVENT OCCURRED IN INPATIENT PEDIATRIC UNITS AND PEDIATRIC INTENSIVE CARE UNITS (PICU), PRIOR TO ATTACHING THE SETS TO THE PATIENTS.
Patient problems: No Patient Involvement
MAUDE report 9782499 ↗MalfunctionMar 3, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING A BD CLINICAL PRACTICE SITE VISIT, IT WAS REPORTED THAT THE TUBING SETS HAD SEPARATED BELOW THE SAFETY CLAMP AS WELL AS AT THE UPPER FITMENT, UPON LOADING THE SET INTO THE PUMP. THE EVENT OCCURRED IN INPATIENT PEDIATRIC UNITS AND PEDIATRIC INTENSIVE CARE UNITS (PICU), PRIOR TO ATTACHING THE SETS TO THE PATIENTS.
Patient problems: No Patient Involvement
MAUDE report 9782495 ↗MalfunctionMar 3, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING A BD CLINICAL PRACTICE SITE VISIT, IT WAS REPORTED THAT THE TUBING SETS HAD SEPARATED BELOW THE SAFETY CLAMP AS WELL AS AT THE UPPER FITMENT, UPON LOADING THE SET INTO THE PUMP. THE EVENT OCCURRED IN INPATIENT PEDIATRIC UNITS AND PEDIATRIC INTENSIVE CARE UNITS (PICU), PRIOR TO ATTACHING THE SETS TO THE PATIENTS.
Patient problems: No Patient Involvement
MAUDE report 9782493 ↗MalfunctionMar 3, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING A BD CLINICAL PRACTICE SITE VISIT, IT WAS REPORTED THAT THE TUBING SETS HAD SEPARATED BELOW THE SAFETY CLAMP AS WELL AS AT THE UPPER FITMENT, UPON LOADING THE SET INTO THE PUMP. THE EVENT OCCURRED IN INPATIENT PEDIATRIC UNITS AND PEDIATRIC INTENSIVE CARE UNITS (PICU), PRIOR TO ATTACHING THE SETS TO THE PATIENTS.
Patient problems: No Patient Involvement
MAUDE report 9782417 ↗MalfunctionMar 3, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING A BD CLINICAL PRACTICE SITE VISIT, IT WAS REPORTED THAT THE TUBING SETS HAD SEPARATED BELOW THE SAFETY CLAMP AS WELL AS AT THE UPPER FITMENT, UPON LOADING THE SET INTO THE PUMP. THE EVENT OCCURRED IN INPATIENT PEDIATRIC UNITS AND PEDIATRIC INTENSIVE CARE UNITS (PICU), PRIOR TO ATTACHING THE SETS TO THE PATIENTS.
Patient problems: No Patient Involvement
MAUDE report 9782416 ↗MalfunctionMar 3, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING A BD CLINICAL PRACTICE SITE VISIT, IT WAS REPORTED THAT THE TUBING SETS HAD SEPARATED BELOW THE SAFETY CLAMP AS WELL AS AT THE UPPER FITMENT, UPON LOADING THE SET INTO THE PUMP. THE EVENT OCCURRED IN INPATIENT PEDIATRIC UNITS AND PEDIATRIC INTENSIVE CARE UNITS (PICU), PRIOR TO ATTACHING THE SETS TO THE PATIENTS
Patient problems: No Patient Involvement
MAUDE report 9782412 ↗MalfunctionJan 28, 2019Failure to Prime
IV TUBING WOULD NOT PRIME PROPERLY. THIS DID NOT REACH A PATIENT, NO HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8280836 ↗
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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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