Alaris, SmartSite 10015012Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, Port (Burette) Y-Site 317 cm (125 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alaris SmartSite pump infusion set is an IV tubing set with a filter used to deliver fluids through an infusion pump. The 87 reports, with no deaths or no injuries, mostly describe tubing and burette parts leaking, cracking, or breaking, plus air in the line and flow problems. Three open recalls remain, covering sets whose performance data fell short of expectations, flow rate and alarm timing issues, and sets labeled as DEHP-free that actually contain DEHP; the most recent began August 2026.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 87
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10885403233951), received between Apr 16, 2019 and Sep 8, 2026 — classified as 87 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (47 reports).
3 FDA recall records name this device's identifier, 3 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.
Reports received per month
Recalls naming this device
- Aug 19, 2026Class IOpen, Classified
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 8, 2025Class IOpen, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Z-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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
- Leak/Splash47
- Crack14
- Air/Gas in Device10
- Break7
- Defective Component7
- Free or Unrestricted Flow4
- Infusion or Flow Problem4
- Device Contamination with Chemical or Other Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Consequences Or Impact To Patient13
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Information1
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Crack; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674222 ↗MalfunctionApr 14, 2026Separation Problem
IT WAS REPORTED BY THE CUSTOMER THAT TUBING DISCONNECTED AT CONNECTION POINT BETWEEN TUBING AND TOP OF BURETROL. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876749 ↗MalfunctionFeb 23, 2026Separation Failure
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423830 ↗MalfunctionFeb 20, 2026Break
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24407784 ↗MalfunctionJan 27, 2026Crack
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WENT TO CLEAR AIR FROM TPN LINE - LINE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24196031 ↗MalfunctionJan 27, 2026Crack
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WENT TO CLEAR AIR FROM TPN LINE - LINE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24190676 ↗MalfunctionJan 22, 2026Material Twisted/Bent
WRITER WAS DOING AN URGENT TPN LINE CAP CHANGE. WENT TO PRIME TPN NOTED DEFECT IN TUBING. PATIENT INJURY: NO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24152369 ↗MalfunctionDec 29, 2025Crack; Crack
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED.THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VEBRATIM. IT WAS REPORTED BY CUSTOMER THAT THE NURSE WENT TO CHECK IV LINES AND PUMPS. TPN LINE REQUIRED MORE TPN IN BURETROL THUS NURSE OPENED CLAMP AND ALLOWED TPN TO FILL BURETROL. NURSE THEN HEARD FUNNY NOISE AND REALIZED THAT THE BRUETROL HAD A CRACK. NURSE DID NOT SQUEEZE THE BURETROL IN FACT WAS NOT EVEN TOUCHING THE BURETROL. NEW TPN TUBING WAS HUNG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23918630 ↗MalfunctionNov 21, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE INFUSION SET HAD A KINK / BEND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HANGING NEW TPN LINE AND KINK NOTED IN THE TPN LINE PASS THE BURETROL AND DRIP CHAMBER. CONCERNED THAT TUBING WOULD LEAK FROM THIS KINKED AREA (NOT CONNECTED TO THE PATIENT). A FEW STAFF HAVE INFORMED THAT THEY HAVE NOTED THE TPN TUBING BEING PACKAGED DIFFERENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23624961 ↗MalfunctionNov 21, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE INFUSION SET HAD A KINK / BEND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HANGING NEW TPN LINE AND KINK NOTED IN THE TPN LINE PASS THE BURETROL AND DRIP CHAMBER. CONCERNED THAT TUBING WOULD LEAK FROM THIS KINKED AREA (NOT CONNECTED TO THE PATIENT). A FEW STAFF HAVE INFORMED THAT THEY HAVE NOTED THE TPN TUBING BEING PACKAGED DIFFERENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23624960 ↗MalfunctionJul 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TUBING FOUND LEAKING FLUID DIRECTLY BELOW DRIP CHAMBER AND WITH SMALL CRACK FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22559688 ↗MalfunctionMay 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TPN BURETROL (THE LITTLE PART) NOTED TO BE LEAKING IN A CORNER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22041224 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT TUBING WITH BURETTE SET NOTED TO LEAK ON THE FLOOR AND AIR IN LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030273 ↗MalfunctionApr 17, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21862484 ↗MalfunctionMar 19, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. TPN LINE AIR ALARM WITH LARGE VOLUME PAST PUMP X2 WITHIN 2 HOURS OF FIXING AIR ALARMS. RN NOTED A LARGE BUBBLE NEAR FILTER AND ELECTED TO DISCONNECT AND PRIME LINE TO REMOVE. ONCE DISCONNECTED AND UNCLAMPED FLUID WENT IN OPPOSITE DIRECTION, AGAINST GRAVITY AND NATURAL MOVEMENT BACK INTO BURETROL - CAUSING TUBING TO BE FULL OF AIR AT THE BOTTOM OF THE LINE AND FLUID WOULD NOT MOVE DOWN DESPITE POSITIONING ATTEMPTS TO ASSIST GRAVITY. RN REPLACED TUBING WITH SET FROM NEW BAG OF SETS IN CARDIAC SUPPLY ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21649441 ↗MalfunctionFeb 7, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED A SMALL CRACK OF THE TPN BURETROL TUBING UNDERNEATH THE DRIP CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334330 ↗MalfunctionFeb 3, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE BURRETROL HAS FLUID IN THE CHAMBER BUT THE TUBING FROM THE BURRETROL TO THE PUMP KEEPS GETTING LARGE AMOUNTS OF AIR IN THE LINE. THIS HAS HAPPENED MORE THAN ONCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21297578 ↗MalfunctionJan 31, 2025Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE BURETROL HAS FLUID IN THE CHAMBER BUT THE TUBING FROM THE BURRETROL TO THE PUMP KEEPS GETTING LARGE AMOUNTS OF AIR IN THE LINE. THIS HAS HAPPENED MORE THAN ONCE. IT ISN'T HAPPENING WHEN THEY ARE PRIMING THE TUBING. IT'S HAPPENING RANDOMLY DURING THE INFUSION WHERE THE TUBING IS JUST 1 LARGE AIR BUBBLE FROM THE DRIP CHAMBER TO THE PART OF THE TUBING THAT GOES INTO THE ALARIS PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21284596 ↗MalfunctionJan 29, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21263430 ↗MalfunctionDec 13, 2024Crack; Crack
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT RN WENT TO CHANGE TPN BAG AND NOTED A CRACK IN THE BURETROL TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20922004 ↗MalfunctionOct 30, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY NOTED LEAK WHERE THE TUBING JOINS THE BURETROL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571253 ↗MalfunctionOct 14, 2024Defective Component; Separation Problem; Defective Component; Separation Problem
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: ¿ TPN FILTER WITH BURETROL TUBING SNAPPED BELOW COLLECTION CHAMBER WHILE TPN INFUSING. ¿ TUBING WAS NOT BENT IN ANY WAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20447718 ↗MalfunctionSep 23, 2024Disconnection; Disconnection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280449 ↗MalfunctionSep 12, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20202014 ↗MalfunctionSep 12, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT BD ALARIS SMARTSITE LOW SORBING SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT NURSE ASSESSING THE TPN BAG AND IV TUBING AND FOUND THE TUBING FILTER WET. NURSE ASSESSING THE TPN BAG AND IV TUBING AND FOUND THE TUBING FILTER WET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20201726 ↗
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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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