Alaris, SmartSite 11609481Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, Low Sorbing Tubing (PE Lined) 2 Y-Sites 318 cm (125 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403232596), received between Jan 10, 2019 and May 22, 2019 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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
- Fluid/Blood Leak4
- Material Puncture/Hole3
- Material Separation3
- Break1
Patient problems
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT THE PUMP WAS ALARMING AIR IN LINE WHILE INFUSING D12.5/TPN TO A NEONATE PATIENT IN THE NICU. THE INFUSION WAS STOPPED, CLAMPED WITH THE SLIDE CLAMP AND THE TUBING WAS REMOVED FROM THE PUMP. THE RN FLICKED THE AIR FROM ITS LOCATION TO DISPLACE IT UPWARD AND THE TUBING BECAME SEPARATED AT THE TOP OF THE SILICONE SEGMENT. A MINIMAL AMOUNT OF TPN WAS LOST SINCE THE TUBING WAS CLAMPED. A REPLACEMENT WAS USED WITH NO FURTHER ISSUES. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8633022 ↗MalfunctionJan 21, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTED THAT THE TUBING CAUSED AN AIR IN LINE ALARM ON THE PUMP FROM A HOLE THAT WAS NOTED IN THE PUMP SEGMENT WHICH LEAKED. THERE WAS NO REPORT OF HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8265758 ↗MalfunctionJan 21, 2019Break; Break
THE CUSTOMER REPORTED THAT THE TUBING SEPARATED/BROKE DURING INFUSION TO A PATIENT. THERE WAS NO REPORT OF HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8265673 ↗MalfunctionJan 11, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTED THAT THERE WAS A HOLE IN THE SEGMENT OF THE TUBING THAT IS INSERTED INTO THE PUMP, RESULTING IN A LEAK. THE EVENT OCCURRED IN THE NICU WITH TPN INFUSING AT 8 ML/HR. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8241528 ↗MalfunctionJan 11, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE CUSTOMER REPORTED THAT THERE WAS A HOLE IN THE SEGMENT OF THE TUBING THAT IS INSERTED INTO THE PUMP, RESULTING IN A LEAK. THE EVENT OCCURRED IN THE NICU WITH TPN INFUSING AT 8 ML/HR. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8241455 ↗MalfunctionJan 10, 2019Material Separation; Material Separation
THE CUSTOMER REPORTED THAT WHILE THE RN WAS REMOVING THE TUBING FROM THE ISOLETTE THE TUBING SEPARATED WHILE INFUSING TPN TO A PATIENT IN THE NICU. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8234447 ↗MalfunctionJan 10, 2019Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE TUBING SEPARATED AT THE FILTER DURING AN INFUSION OF TPN TO A PATIENT IN THE NICU. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8234446 ↗
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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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