Alaris, SmartSite 20027ERecalls & reported problems

Summary

The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 10885403234859), received between Oct 24, 2018 and Sep 29, 2026 — classified as 1 death, 3 injuries, 179 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (71 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

Recent adverse event reports

The 25 most recent of 183 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936979 ↗
• MalfunctionSep 24, 2026Leak/Splash

  It was reported that BD smartsite extension set was leaking.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that while preparing a CSP and priming the line with drug the tubing was found to be leaking out of the 0.2-micron filter. The leaking tubing was identified prior to interaction with a patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889056 ↗
• MalfunctionSep 17, 2026Leak/Splash

  It was reported that BD smartsite extension set was crackedThe following information was received by the initial reporter with the following VerbatimIt was reported by customer that leaking and cracked line.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797236 ↗
• MalfunctionSep 3, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50593006 ↗
• MalfunctionAug 4, 2026Complete Blockage; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132886 ↗
• InjuryAug 3, 2026Leak/Splash

  It was reported that the BD Alaris SmartSite Extension Set had leakage.The following information was provided by the initial reporter: leaking from extension set.Additional Information Received from the Customer:Please provide the exact event date in MM-DD-YYYY format. If multiple incidents occurred, kindly provide the corresponding event date for each incident. (b)(6)2026.Please provide the Batch# or Lot# number? Unknown.What was the medication/fluid in use at the time of the event? Yes; TPN.Describe any patient¿s harm, injury, complication or negative outcome that occurred as a result of the event. Patient had a low blood glucose and required a D10 bolus and hourly BG checks for several hours. Patient is now back to their baseline and back on their TPN.

  Patient problems: Hypoglycemia

  MAUDE report 50124253 ↗
• InjuryAug 3, 2026Leak/Splash

  It was reported that the BD Alaris SmartSite Extension Set had leakage.The following information was provided by the initial reporter: leaking from extension setAdditional Information Received from the Customer:Please provide the exact event date in MM-DD-YYYY format. If multiple incidents occurred, kindly provide the corresponding event date for each incident. 6/10/2026.Please provide the Batch# or Lot# number? Unknown.What was the medication/fluid in use at the time of the event? Yes; TPN.Describe any patient¿s harm, injury, complication or negative outcome that occurred as a result of the event. Patient had a low blood glucose and required a D10 bolus and hourly BG checks for several hours. Patient is now back to their baseline and back on their TPN.

  Patient problems: Hypoglycemia

  MAUDE report 50124251 ↗
• MalfunctionAug 1, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50108050 ↗
• MalfunctionJul 10, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788410 ↗
• MalfunctionMay 18, 2026Complete Blockage

  IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT FLUID WILL NOT FLOW PAST THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25208063 ↗
• MalfunctionApr 22, 2026Leak/Splash; Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAILURE OF BD EXTENSION SET IDENTIFIED, 2 OCCURRENCES. RN REPORTED LEAKING WHEN EXTENSION SET WAS ATTACHED TO THE FLUSH BAG. THE SECOND THEN CAME APART IN HER HANDS WHEN TRYING TO REPLACE THE 1ST SET, WHICH HAD LEAKED. IT APPEARS THAT THERE IS NO SEALANT PRESENT. PT CODE: 4582. DEVICE CODES: 1250, 2907. REF REPORT: MW5184749.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957002 ↗
• MalfunctionApr 22, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAILURE OF BD EXTENSION SET IDENTIFIED, 2 OCCURRENCES. RN REPORTED LEAKING WHEN EXTENSION SET WAS ATTACHED TO THE FLUSH BAG. THE SECOND THEN CAME APART IN HER HANDS WHEN TRYING TO REPLACE THE 1ST SET, WHICH HAD LEAKED. IT APPEARS THAT THERE IS NO SEALANT PRESENT. PT CODE: 4582. DEVICE CODES: 1250, 2907. REF REPORT: MW5184749.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957001 ↗
• MalfunctionApr 21, 2026Separation Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945140 ↗
• MalfunctionApr 21, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT RN REPORTED LEAKING WHEN EXTENSION SET WAS ATTACHED TO THE FLUSH BAG. THE SECOND THEN CAME APART IN HER HANDS WHEN TRYING TO REPLACE THE 1ST SET, WHICH HAD LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945137 ↗
• MalfunctionApr 13, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WALKED INTO ROOM; THERE WAS A PUDDLE ON THE FLOOR NEXT TO PATIENT. UPON INSPECTION RN REALIZED THAT THE AMIODARONE TUBING WAS WET, UPON INSPECTION THE FILTER HAD BROKEN FROM THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860394 ↗
• MalfunctionApr 1, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757178 ↗
• MalfunctionMar 31, 2026Separation Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING ON ONE SIDE OF THE FILTER DISLODGED FROM THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747206 ↗
• MalfunctionMar 31, 2026Complete Blockage

  IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT FLUID WILL NOT FLOW PAST THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746543 ↗
• MalfunctionMar 24, 2026Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT MARCH 2ND WE HAVE HAD 2 BD 0.2 MICRON LOW PROTEIN BINDING FILTERS (BD SMARTSITE EXTENSION SET) THAT WOULD NOT PRIME/FLUSH AND MARCH 3RD NURSE WAS INFUSING DEXAMETHASONE(NO CYTOTOXICS) THROUGH A BD ALARIS TUBING SET WITH A 0.2 MICRON FILTER (NO PACKAGE BUT SAME PRODUCT AS ABOVE) AND THE IV BEGAN LEAKING AT THE FILTER WHERE THE TUBING CONNECTS TO THE ACTUAL FILTER AND FEBRUARY 20TH SAME FILTER PRODUCT AS ABOVE. WAS LEAKING AND THEN SEPARATED AT THE SPOT WHERE THE TUBING CONNECTS TO THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681152 ↗
• MalfunctionMar 24, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT (B)(6) WE HAVE HAD 2 BD 0.2 MICRON LOW PROTEIN BINDING FILTERS (BD SMARTSITE EXTENSION SET) THAT WOULD NOT PRIME/FLUSH AND (B)(6) NURSE WAS INFUSING DEXAMETHASONE(NO CYTOTOXICS) THROUGH A BD ALARIS TUBING SET WITH A 0.2 MICRON FILTER (NO PACKAGE BUT SAME PRODUCT AS ABOVE) AND THE IV BEGAN LEAKING AT THE FILTER WHERE THE TUBING CONNECTS TO THE ACTUAL FILTER AND (B)(6) SAME FILTER PRODUCT AS ABOVE. WAS LEAKING AND THEN SEPARATED AT THE SPOT WHERE THE TUBING CONNECTS TO THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675148 ↗
• MalfunctionMar 24, 2026Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT MARCH 2ND WE HAVE HAD 2 BD 0.2 MICRON LOW PROTEIN BINDING FILTERS (BD SMARTSITE EXTENSION SET) THAT WOULD NOT PRIME/FLUSH AND MARCH 3RD NURSE WAS INFUSING DEXAMETHASONE(NO CYTOTOXICS) THROUGH A BD ALARIS TUBING SET WITH A 0.2 MICRON FILTER (NO PACKAGE BUT SAME PRODUCT AS ABOVE) AND THE IV BEGAN LEAKING AT THE FILTER WHERE THE TUBING CONNECTS TO THE ACTUAL FILTER AND FEBRUARY 20TH SAME FILTER PRODUCT AS ABOVE. WAS LEAKING AND THEN SEPARATED AT THE SPOT WHERE THE TUBING CONNECTS TO THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675145 ↗
• MalfunctionMar 18, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635023 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak; Leak/Splash

  ADDITIONAL INFORMATION:ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NOCAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632159 ↗
• MalfunctionMar 12, 2026Obstruction of Flow

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587272 ↗
• MalfunctionJan 29, 2026Fluid/Blood Leak

  IT IS REPORTED LEAKAGE. DESCRIPTION: BD SMARTSITE EXTENSION SET SHOWED SIGNS OF LEAKAGE AROUND THE EDGES OF THE FILTER DURING AN INFUSION OF PEMBROLIZUMAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209461 ↗