Alaris, SmartSite 10053857Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403234125), received between Mar 25, 2020 and Dec 27, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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.

• MalfunctionDec 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT 2 OF THE BD GRAVITY ADMINISTRATION SET DISCONNECTING BELOW THE DRIP CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FASC HAS HAD 3 REPORTS OF BD SMARTSITE GRAVITY SETS REF. 100053857 DISCONNECTING BELOW THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056808 ↗
• MalfunctionOct 13, 2022No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS SMARTSITE GRAVITY SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF HAD TO GO THROUGH A FEW IV GRAVITY SETS BEFORE THEY FOUND ONE THAT WORKED. THE TUBING THAT CONNECTS WILL NOT FLOW ONCE IV FLUIDS ARE PUNCTURED AND THE DIP CHAMBER WILL NOT FILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601378 ↗
• MalfunctionFeb 9, 2022Leak/Splash; Incomplete or Inadequate Connection; Leak/Splash; Incomplete or Inadequate Connection

  IT WAS REPORTED WHILE USING ALARIS SMARTSITE GRAVITY SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 10053857, BATCH #: 20129628. VERBATIM: NOTICE DRIPPING OF MEDICATION AT THE FILTER UPON STARTING THE INFUSION. NO MEDICATION TOUCHED PATIENT. FILTER REPLACED WITH A NEW ONE. INFUSION STARTED WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502287 ↗
• MalfunctionJan 10, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE¿ GRAVITY SET WAS FALLING APART DUE TO IMPROPER GLUING. THIS EVENT OCCURRED 6 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE GETTING REPORTS THAT THE GRAVITY 15GTT SET IS FALLING APART, NOT PROPERLY GLUED!!"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13213349 ↗
• MalfunctionDec 1, 2021Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT 2 BD GRAVITY V/NV CKV 2SS 15D DEHP-FREE EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD AN INCIDENT REGARDING THE USE OF THE BD SMARTSITE GRAVITY INFUSION SET. ON TWO SEPARATE OCCASIONS TODAY WITH TWO SEPARATE NURSES, THE BD SMARTSITE GRAVITY SET MALFUNCTIONED. BOTH NURSES PRIMED THEIR SOLUTION BAGS AND SOON AFTER HANGING THE BAGS ON THE POLE, THE TUBING CAME APART AT THE CHAMBER CONNECTION SITE. THE FIRST BAG CAUSED AN EXPENSE WASTE AND THE SECOND WAS JUST NORMAL SALINE.

  Patient problems: Insufficient Information

  MAUDE report 12912919 ↗
• MalfunctionJan 15, 2021Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 3 GRAVITY V/NV CKV 2SS 15D DEHP-FREE WERE CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FLUID WILL NOT DRAIN FROM THE DRIP CHAMBER. THE OUTLET SEEMS TO BE FUSED. IN THE LAST BATCH OF GRAVITY IV TUBING WE RECEIVED WE HAVE HAD 3 SO FAR THAT ARE FUSED DIRECTLY UNDER THE DRIP CHAMBER AND DO NOT WORK. I HAVE A SINGLE GRAVITY SET IN MY OFFICE FOR YOU, #10053857. THE FLUID WILL NOT DRAIN FROM THE DRIP CHAMBER. THE OUTLET SEEMS TO BE FUSED. LOT # (10)20076679. IT HAPPENED TWICE THAT DAY. BUT MY STAFF DID SAY IT HAPPENED ONCE THE WEEK BEFORE ( I WAS OUT WITH COVID DURING THAT TIME AND THE PACKAGE WAS NOT SAVED).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11175816 ↗
• MalfunctionMar 25, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT WHILE ATTEMPTING TO PRIME THE TUBING WITH 1 LITER NORMAL SALINE, THE TUBING SEPARATED AT THE NEEDLELESS CONNECTOR. THE EVENT OCCURRED AT THE EMERGENCY DEPARTMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878273 ↗
• MalfunctionMar 25, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE TUBING SEPARATED AND LEAKED WHILE NORMAL SALINE WAS INFUSING. THE EVENT OCCURRED AT THE EMERGENCY DEPARTMENT. THE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878206 ↗