Alaris, SmartSite 10802688Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10885403234439), received between May 10, 2019 and Sep 24, 2026 — classified as 96 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (33 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890864 ↗
• MalfunctionJun 12, 2026Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SO, WE HAVE HAD 2 OF THESE IV TUBINGS FAIL US AFTER BEING ATTACHED TO THE PATIENT. WE ARE ABLE TO PRIME THE TUBING INITIALLY, BUT ONCE IT IS HOOKED TO THE IV IT WILL NOT FLOW. WE HAVE CHECKED FOR KINKS, OPENED THE RELEASE VALVE AND HAD NO SUCCESS. WE EVEN TRIED SWITCHING OUT THE IV BAG. FINALLY, WE SWITCHED OUT THE TUBING FOR ANOTHER SET AND IT WORKED. # OF OCCURRENCES: 2. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 05-12-2026. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 1ST OCCURRENCE: WHEN THE FLUID WOULD NOT FLOW THROUGH THE INITIAL IV THE NURSE RESTARTED THE IV THINKING THAT THE IV WAS BAD, BUT THEN SHE REALIZED IT WAS THE TUBING THAT FAILED SO THIS PATIENT HAD A SECOND POKE UNNECESSARILY. 2ND OCCURRENCE: THE PROCEDURE WAS DELAYED 5 MINUTES WHEN THE NURSE HAD TO TROUBLESHOOT WHY THE FLUID WASN'T FLOWING. IT ALSO MADE THE PATIENT MORE ANXIOUS IN AN ALREADY VULNERABLE SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494230 ↗
• MalfunctionJun 12, 2026Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SO, WE HAVE HAD 2 OF THESE IV TUBINGS FAIL US AFTER BEING ATTACHED TO THE PATIENT. WE ARE ABLE TO PRIME THE TUBING INITIALLY, BUT ONCE IT IS HOOKED TO THE IV IT WILL NOT FLOW. WE HAVE CHECKED FOR KINKS, OPENED THE RELEASE VALVE AND HAD NO SUCCESS. WE EVEN TRIED SWITCHING OUT THE IV BAG. FINALLY, WE SWITCHED OUT THE TUBING FOR ANOTHER SET AND IT WORKED. # OF OCCURRENCES: 2. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? (B)(6) 2026. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 1ST OCCURRENCE: WHEN THE FLUID WOULD NOT FLOW THROUGH THE INITIAL IV THE NURSE RESTARTED THE IV THINKING THAT THE IV WAS BAD, BUT THEN SHE REALIZED IT WAS THE TUBING THAT FAILED SO THIS PATIENT HAD A SECOND POKE UNNECESSARILY. 2ND OCCURRENCE: THE PROCEDURE WAS DELAYED 5 MINUTES WHEN THE NURSE HAD TO TROUBLESHOOT WHY THE FLUID WASN¿T FLOWING. IT ALSO MADE THE PATIENT MORE ANXIOUS IN AN ALREADY VULNERABLE SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494227 ↗
• MalfunctionJan 26, 2026No Flow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD AN OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I JUST RECEIVED COMPLAINT ABOUT PRODUCT NUMBER 10802688 BD SMARTSITE GRAVITY SET 10ML. I WAS TOLD THAT IT "WILL NOT RUN FLUIDS THROUGH THE TUBING EVEN WHEN ATTACHED TO A SYRINGE TO PULL FLUID. IT WILL ONLY FILL THE CHAMBER HALF WAY". CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 12-31-2025 IS THE DATE I WAS FIRST NOTIFIED. I WAS JUST TOLD THIS MORNING THAT THIS HAS BEEN HAPPENING ALMOST EVERYDAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180435 ↗
• MalfunctionJan 20, 2026Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I JUST RECEIVED COMPLAINT ABOUT PRODUCT NUMBER 10802688 BD SMARTSITE GRAVITY SET 10ML. I WAS TOLD THAT IT "WILL NOT RUN FLUIDS THROUGH THE TUBING EVEN WHEN ATTACHED TO A SYRINGE TO PULL FLUID. IT WILL ONLY FILL THE CHAMBER HALF WAY". ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 12-31-2025. IS THE DATE I WAS FIRST NOTIFIED. I WAS JUST TOLD THIS MORNING THAT THIS HAS BEEN HAPPENING ALMOST EVERY DAY. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT NUMBER IS (10)25095413 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. I WAS NOT MADE AWARE OF ANY ISSUES OTHER THAN A SLIGHT DELAY IN THE DAY, DUE TO PRODUCT FAILING AND HAVING TO OPEN ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120750 ↗
• MalfunctionJan 20, 2026Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I JUST RECEIVED COMPLAINT ABOUT PRODUCT NUMBER 10802688 BD SMARTSITE GRAVITY SET 10ML. I WAS TOLD THAT IT "WILL NOT RUN FLUIDS THROUGH THE TUBING EVEN WHEN ATTACHED TO A SYRINGE TO PULL FLUID. IT WILL ONLY FILL THE CHAMBER HALF WAY". ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 12-31-2025 IS THE DATE I WAS FIRST NOTIFIED. I WAS JUST TOLD THIS MORNING THAT THIS HAS BEEN HAPPENING ALMOST EVERY DAY. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT NUMBER IS (10)25095413 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. I WAS NOT MADE AWARE OF ANY ISSUES OTHER THAN A SLIGHT DELAY IN THE DAY, DUE TO PRODUCT FAILING AND HAVING TO OPEN ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120710 ↗
• MalfunctionDec 8, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT OCCURRED 3 TIMES. THE VALVE PROXIMAL TO THE PATIENT ON THE BD TUBING DID NOT DEPLOY. IT SIMPLY DID NOT WORK (TOTAL OCCLUSION). THIS INCIDENT HAPPENED TWICE WITH A SYRINGE PUMP TUBING (REF (B)(6)). IT HAPPENED ANOTHER TIME WITH B-BRAUN TUBING ((B)(6)). WE NOTICED IT BEFORE ANESTHETIZING THE PATIENT (SO THERE WERE NO CONSEQUENCES FOR THE PATIENT). INCIDENTS X3 OCCURRED IN THE WEEK OF OCTOBER 20, 2025. THIS PROBLEM HAS ALREADY BEEN RAISED BY HDQ, AND THE TUBINGS ARE STILL IN CIRCULATION. COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: A FEW TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739580 ↗
• MalfunctionDec 8, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739508 ↗
• MalfunctionNov 19, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE IV WOULD NOT FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595774 ↗
• MalfunctionNov 11, 2025Product Quality Problem; Blocked Connection; Product Quality Problem; Blocked Connection

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528803 ↗
• MalfunctionNov 11, 2025Product Quality Problem; Blocked Connection; Product Quality Problem; Blocked Connection

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE TUBE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528801 ↗
• MalfunctionOct 22, 2025Complete Blockage; Material Deformation; Complete Blockage; Material Deformation

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. THERE WAS A KINK IN THE LINE WHICH DIDN¿T ALLOW FLUID TO PASS THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364079 ↗
• MalfunctionSep 12, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE ON-SITE FOR REVIEW OF CONCERNS WITH IV SET REFERENCE #10802688 IT WAS REPORTED TO ME THAT SEVERAL OF THIS PARTICULAR IV ADMINISTRATION SET (APPROXIMATELY 13) COMPLAINTS WERE COMMUNICATED BY NURSING STAFF TO THE SUPPLY CHANGE MANAGER THAT SETS "FELL APART" AT THE JUNCTURE BETWEEN THE DRIP CHAMBER AND THE IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038737 ↗
• MalfunctionSep 12, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE ON-SITE FOR REVIEW OF CONCERNS WITH IV SET REFERENCE #10802688 IT WAS REPORTED TO ME THAT SEVERAL OF THIS PARTICULAR IV ADMINISTRATION SET HAD A NOTICEABLE "KINK" JUST BELOW THE DRIP CHAMBER THAT APPEARED TO BE FUSED TOGETHER NOT ALLOWING FREE FLOW OF IV FLUID DOWN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038644 ↗
• MalfunctionAug 6, 2025Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734000 ↗
• MalfunctionAug 6, 2025Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733998 ↗
• MalfunctionJul 31, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿RE HAVING AN ISSUE WITH ITEM#10802688, IV GRAVITY SET WITH CHECK VALVE. THE TUBE IS BENT MAKING IV FLUID UNABLE TO PASS THROUGH. ALL ARE FROM LOT#(10)25019445 AND LOT#(10)24129019.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680261 ↗
• MalfunctionJul 31, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿RE HAVING AN ISSUE WITH ITEM#10802688, IV GRAVITY SET WITH CHECK VALVE. THE TUBE IS BENT MAKING IV FLUID UNABLE TO PASS THROUGH. ALL ARE FROM LOT#(10)25019445 AND LOT#(10)24129019.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680260 ↗
• MalfunctionJul 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT WHEN CONNECTING SECONDARY ABX IV TUBING TO PRIMARY NS TUBING AND OPENING CLAMPS, SECONDARY TUBING SUDDENLY DISCONNECTED AT Y-SITE. NS FLUID WAS FLOWING OUT OF BROKEN TUBING, THIS RN CLAMPED BOTH IV TUBING AND PLACED FAULTY SUPPLIES INTO BAG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495668 ↗
• MalfunctionJun 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING HAS COME OUT OF THE PORT SITES RENDERING THE IV TUBING NULL AND THE TUBING NOT CONTINUOUS, STERILE, NOR CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330258 ↗
• MalfunctionMay 19, 2025Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TUBING TENDS TO "KINK" ONCE IT IS PUT BACK IN THE IV WARMER. THEY HAD EXPERIENCED TWO TUBINGS THAT THE BLOOD WENT UP TO THE FIRST INJECTION SITE AND EVEN EXCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049104 ↗
• MalfunctionMay 17, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TUBING TENDS TO "KINK" ONCE IT IS PUT BACK IN THE IV WARMER. THEY HAD EXPERIENCED TWO TUBINGS THAT THE BLOOD WENT UP TO THE FIRST INJECTION SITE AND EVEN EXCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041221 ↗
• MalfunctionApr 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS AN ISSUE WITH THE TUBING OR ITS CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860276 ↗
• MalfunctionMar 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE WENT TO HANG A SOLUTION ON A PATIENT, THE TUBE CAME OUT OF THE CLAVE. WE DIDN'T HAVE ANY PATIENT INJURIES BUT I WANTED TO REPORT FOR A QUALITY CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607495 ↗
• MalfunctionFeb 19, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS MISSING COMPONENT. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE BIV TIBING SET DID NOT HAVE ROLLER CLAMP ON TUBING AS SHOWN ON PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412854 ↗