Alaris, SmartSite 2450-0500Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 2 Ganged 3-Way Stopcocks, 3 Y-Sites 327 cm (129 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403235115), received between Jul 17, 2018 and Feb 28, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Oct 11, 2023Class IIOpen, Classified
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Z-0349-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak2
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE INFUSION SET A PART OF THE DEVICE DETACHED FROM THE REST WITHOUT WARNING THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2450-0500. BATCH #: UNKNOWN. THE CUSTOMER HAS EXPERIENCED ISSUES WITH THE STOPCOCK BECOMING DETACHED FROM THE SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13623572 ↗MalfunctionAug 9, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "PATIENT WAS IN CT SCAN, TO RECEIVE IV CONTRAST THROUGH HER PORTACATH IV WAS CONNECTED TO IV INFUSION PUMP AT 20ML/HR IV TUBING CLAMPED AT THE ROLLER CLAMP MID TUBING AND DISTAL PORT CLAMP. IV CONTRAST INFUSING AND TUBING BROKE AT TOP OF IV INFUSION PUMP AT CONNECTOR ABOVE SOFT TUBING, LEAKING NORMAL SALINE." THE EVENT OCCURRED IN THE EMERGENCY DEPARTMENT. THERE WAS NO PATIENT HARM. IT WAS CONFIRMED THAT THE IV CONTRAST WAS GIVEN ABOVE THE SMARTSITE IV PUMP MODULE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8879569 ↗MalfunctionJul 17, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE SET WAS DRIPPING BLOOD ON THE PATIENT. THE CUSTOMER REPORTED THIS WAS A MATTER OF NOT SECURING ALL OF THE CONNECTIONS OUT OF THE PACKAGE PRIOR TO USING THE TUBING. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7694310 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 · each recall links to the FDA recall notice
- 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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