Alaris, SmartSite 10037032Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403244056), received between Jan 18, 2022 and Mar 21, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BOTTOM OF THE BD ALARIS¿ SMARTSITE¿ GRAVITY BURETTE SET SEPARATED FROM THE CHAMBER OF THE BURRETTE AND LEAKED. ADDITIONALLY, 2 OTHER SETS ALSO SEPARATED FROM THE CHAMBER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD ANOTHER INCIDENCE OF THE BOTTOM POPPING OFF THE CHAMBER OF THE BURETTE ON THESE SETS ¿ ONE EXPLODED IN USE AND OUR LEAD AT HAS BOUGHT ME ANOTHER TWO FAULTY SETS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586848 ↗
• MalfunctionJan 28, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BOTTOM OF THE BD ALARIS¿ SMARTSITE¿ GRAVITY BURETTE SET SEPARATED WHILE BEING FILLED AND LEAKED OUT ANTIBIOTICS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOTTOM OF THE BURETTES CAME OFF WHEN FILLED. ONE NURSE LOST A DOSE OF ANTIBIOTICS. ONLY SALINE WAS LOST IN OTHER INSTANCES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261162 ↗
• MalfunctionDec 5, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT 5 BD ALARIS SMARTSITE GRAVITY BURETTE SETS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 5 UNITS OF BURETTES WITH THE SAME LOT NUMBER WERE IDENTIFIED TO HAVE COME APART BETWEEN THE CHAMBER AND BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15917647 ↗
• MalfunctionOct 13, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT 3 BD ALARIS SMARTSITE GRAVITY BURETTE SETS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON ALL OCCASIONS THE LINE HAD NOT YET BEEN CONNECTED TO THE PATIENT. THE NURSES WERE SHOWERED WITH ANTIBIOTIC FROM THE BURETTE WHEN IT DROPPED TO THE FLOOR AND NACL FROM THE IV FLUID BAG. THEY HAD TO OPEN NEW GIVING SETS AND ARE NOW TAPING THE WHITE DISK TO THE BURETTE TO PREVENT IT FROM HAPPENING AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601051 ↗
• MalfunctionApr 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BD ALARIS SMARTSITE GRAVITY BURETTE SET HAD A COMPONENT SEPARATION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BASE OF BURETTE CAME OFF DURING USE, SALINE GIVEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021955 ↗
• MalfunctionMar 15, 2022Leak/Splash; Separation Problem; Leak/Splash; Separation Problem

  IT WAS REPORTED THAT 2 BD ALARIS SMARTSITE GRAVITY BURETTE SETS EXPERIENCED LEAKAGE, AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BURETTE LEAKS AND THEN THE BOTTOM OF BURETTE SET CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771678 ↗
• MalfunctionMar 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 5 BD ALARIS¿ SMARTSITE¿ GRAVITY BURETTE SETS LEAKED FLUID DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS CONFIRMED THAT THE BURETTE IS LEAKING FLUID DURING THE USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759433 ↗
• MalfunctionJan 18, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 20 BD ALARIS¿ SMARTSITE¿ GRAVITY BURETTE SETS CAME APART EITHER WHILE PRIMING THEM WITH SALINE OR DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SEVERAL INCIDENTS OVER THE LAST FEW WEEKS WHERE THE BOTTOM OF THE BURRETE DISCONNECTS DURING USE. SOME INCIDENTS HAVE OCCURRED DURING PRIMING OF THE SET WHILST OTHERS HAVE OCCURRED DURING INFUSION OF SALINE... THE ISSUE IS THAT THE BOTTOM PART OF THE BURRETTE IS FALLING OFF DURING PRIMING. THERE HAS ALSO BEEN INCIDENTS WHERE THE BOTTOM OF THE BURRETTE HAS COME APART DURING USE (DURING INFUSION)"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285051 ↗