Alaris, SmartSite 20128ERecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07613203011839), received between Aug 10, 2018 and Aug 7, 2024 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (24 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT FILTER TUBING COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927239 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT FILTER TUBING COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927238 ↗
• MalfunctionMar 26, 2024Defective Component; Infusion or Flow Problem; Defective Component; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 20128E, BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY ARE LOOKING FOR ALTERNATIVES TO OUR CURRENT FILTER THEY USE IN OUR NICU. THEY USE REF 20128E BD SMARTSITE EXTENSION SET BUT ARE HAVING ISSUES WITH THEM BLOWING. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM LOOKING FOR ALTERNATIVES TO OUR CURRENT FILTER WE USE IN OUR NICU. WE USE REF 20128E BD SMARTSITE EXTENSION SET BUT ARE HAVING ISSUES WITH THEM BLOWING. CUSTOMER REPLY: FOR THE PURPOSES OF CLARIFICATION, I WANT TO DEFINE THE WORD BEING USED TO DESCRIBE YOUR EVENTS "BLOWING" AS NOT BREAKING, CRACKING, LEAKING OR SPECIFICALLY OCCLUSIONS BUT RATHER YOUR INFUSIONS BACKING UP THE LINE. THIS IS IMPORTANT FOR OUR DATA AND TO BE ON THE SAME PAGE. WHAT IS THE DATE OF EVENT? THIS HAS OCCURRED SEVERAL TIMES OVER THE PAST YEAR. PLEASE SHARE THE LOT NUMBER. DON¿T HAVE THOSE NUMBERS AT THIS TIME. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT. NEGATIVE OUTCOME IS THAT WE HAVE TO REPLACE THE FILTER. POTENTIAL HARM IS AIR EMBOLISM IF WE DID NOT REPLACE THE FILTER. ANY SAMPLE AVAILABLE FOR INVESTIGATION?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978172 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584310 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 15TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583799 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 19TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583597 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 13TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583503 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 14TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583360 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 16TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583109 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 17TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582873 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 8TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582872 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 18TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582870 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 9TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582716 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 8TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582698 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576728 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576717 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576674 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576664 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 12TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576584 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 12TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576583 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 6TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576559 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED AROUND THE FILTER AND CONNECTION SITES DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 10TH OF 19 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD MULTIPLE SAFETY REPORTS REGARDING THIS TUBING RELATED TO LEAKING BOTH AROUND THE FILTER AND THE CONNECTIONS. TWELVE INCIDENTS IN THE PAST MONTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576539 ↗
• MalfunctionJan 18, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT ONE BD ALARIS¿ SMARTSITE¿ EXTENSION SET EACH FROM LOTS 22029255 AND AN UNSPECIFIED LOT HAD ISSUES WITH OCCLUSION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PRIMING WITH LIPIDS WE HAVE HAD ISSUES WITH THE PUMPS ALARMING OCCLUDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200374 ↗
• MalfunctionJul 12, 2022Complete Blockage; Air/Gas in Device; Complete Blockage; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED OCCLUSION AND AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS TIME THE NURSE NOTED INCREASED RESISTANCE WHILE PRIMING AND LOTS OF AIR IN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992293 ↗
• MalfunctionMay 23, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 2 BD ALARIS SMARTSITE EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE TWO SETS OF THE SMARTSITE EXTENSION SET FILTER TUBING WITH REF #(B)(4) THAT WOULD NOT PRIME FOR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14477863 ↗