Alaris, SmartSite 11484001Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, Y-Site 268 cm (105 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 10885403232299), received between Jul 10, 2019 and Sep 3, 2019 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Disconnection” (5 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
- Disconnection5
- Fluid/Blood Leak2
Patient problems
- No Information4
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE NICU DEPARTMENT HAS EXPERIENCED AN UNSPECIFIED NUMBER OF EVENTS IN WHICH THE TUBING SET IS UNINTENTIONALLY DISCONNECTING FROM THE PRECEDEX IV BAG DURING USE WITHOUT SPECIFIC DETAILS REGARDING THE EVENTS. ALTHOUGH REQUESTED, THERE WAS NO INFORMATION GIVEN REGARDING PATIENT HARM REPORTED BY THE CUSTOMER.
Patient problems: No Information
MAUDE report 8957867 ↗MalfunctionAug 29, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE NICU DEPARTMENT HAS EXPERIENCED AN UNSPECIFIED NUMBER OF EVENTS IN WHICH THE TUBING SET IS UNINTENTIONALLY DISCONNECTING FROM THE PRECEDEX IV BAG DURING USE WITHOUT SPECIFIC DETAILS REGARDING THE EVENTS. ALTHOUGH REQUESTED, THERE WAS NO INFORMATION GIVEN REGARDING PATIENT HARM REPORTED BY THE CUSTOMER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8948019 ↗MalfunctionAug 29, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE NICU DEPARTMENT HAS EXPERIENCED AN UNSPECIFIED NUMBER OF EVENTS IN WHICH THE TUBING SET IS UNINTENTIONALLY DISCONNECTING FROM THE PRECEDEX IV BAG DURING USE WITHOUT SPECIFIC DETAILS REGARDING THE EVENTS. ALTHOUGH REQUESTED, THERE WAS NO INFORMATION GIVEN REGARDING PATIENT HARM REPORTED BY THE CUSTOMER.
Patient problems: No Information
MAUDE report 8947356 ↗MalfunctionAug 28, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE TUBING SET UNINTENTIONALLY DISCONNECTED TWICE FROM THE PRECEDEX IV BAG DURING USE ON THE SAME BABY IN THE NICU.
Patient problems: No Information
MAUDE report 8940791 ↗MalfunctionAug 28, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE TUBING SET UNINTENTIONALLY DISCONNECTED TWICE FROM THE PRECEDEX IV BAG DURING USE ON THE SAME BABY IN THE NICU.
Patient problems: No Information
MAUDE report 8940789 ↗MalfunctionJul 17, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE NURSE RESPONDED TO THE DEVICE ALARMING "AIR-IN-LINE" TO FIND THAT THE TPN IV BAG WAS EMPTY AND THAT THE TUBING SET HAD LEAKED AFTER BEING IN USE FOR APPROXIMATELY 12 HOURS IN THE NICU. THE INFANT PATIENT REQUIRED A NEW TPN IV BAG TO BE PREPARED. THE CUSTOMER LATER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8799111 ↗MalfunctionJul 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
THIS PRODUCT WAS RECEIVED UNEXPECTEDLY AND UPON INVESTIGATION WAS FOUND TO HAVE A LEAK. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8776738 ↗
Other Set, administration, intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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