Alaris, SmartSite 2441-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10885403235047), received between Oct 10, 2018 and Sep 8, 2026 — classified as 97 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (37 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Aug 19, 2026Class IOpen, Classified

   Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

   Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Oct 11, 2023Class IIOpen, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0349-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678257 ↗
• MalfunctionJun 25, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT CAME FOR IVIG INFUSION. INFUSION WAS STARTED AND PRIMED WITH BURETROL TUBING. AFTER SOME POINT, IVIG WOULD NOT FOLLOW FROM BOTTLE INTO THE BURETROL. NORMAL TROUBLESHOOTING WITH SYRINGES WAS TRIED WITH MULTIPLE ATTEMPTS. PUSHING/ASPIRATING FROM THE BURETROL LUER LOCK, THOUGH FLOW INTO BURETROL WAS UNSUCCESSFUL. REMAINING GAMMA IN IV TUBING WAS ASPIRATED WITH A 20CC SYRINGE AND THE GAMMA WAS RE-PRIMED WITH STRAIGHT TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626465 ↗
• MalfunctionJun 15, 2026Complete Blockage

  IT WAS REPORTED THAT BD ALAIRS SMARTSITE PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT A BURETROL IV-LINE SET WAS USED, THE LUER LOCK PORT ON THE BURETROL WAS DEFECTIVE. WHEN SYRINGE WAS ATTACHED TO PORT UNABLE TO PUSH IN FLUID OR DRAW BACK ON SYRINGE. WHEN RN NEEDED TO REMOVE AIR BUBBLES FROM THE IV TUBING, THEY WERE UNABLE TO PUT THE REMOVED IVIG BACK INTO THE BURETROL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511619 ↗
• MalfunctionJun 15, 2026Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD AIR BUBBLES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT A BURETROL IV-LINE SET WAS USED, THE LUER LOCK PORT ON THE BURETROL WAS DEFECTIVE. WHEN SYRINGE WAS ATTACHED TO PORT UNABLE TO PUSH IN FLUID OR DRAW BACK ON SYRINGE. WHEN RN NEEDED TO REMOVE AIR BUBBLES FROM THE IV TUBING UNABLE TO PUT THE REMOVED IVIG BACK INTO THE BURETRO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511618 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PRIMING THE BURETTE AND PRIMARY TUBING FOR IVIG ADMINISTRATION, THE RN FOLLOWED PROPER VENTING TECHNIQUE. WHILE GENTLY COMPRESSING THE BURETTE TO PRIME THE LINE, THE BURETTE TUBING RUPTURED. A SECOND ATTEMPT WAS MADE USING A NEW BURETTE, AT WHICH POINT LEAKING FROM THE BURETTE TUBING WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009435 ↗
• MalfunctionApr 27, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PRIMING THE BURETTE AND PRIMARY TUBING FOR IVIG ADMINISTRATION, THE RN FOLLOWED PROPER VENTING TECHNIQUE. WHILE GENTLY COMPRESSING THE BURETTE TO PRIME THE LINE, THE BURETTE TUBING RUPTURED. A SECOND ATTEMPT WAS MADE USING A NEW BURETTE, AT WHICH POINT LEAKING FROM THE BURETTE TUBING WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009429 ↗
• MalfunctionApr 27, 2026Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT "THE BURETROL PULLED AIR THROUGH THE PUMP INSTEAD OF MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25007999 ↗
• MalfunctionApr 23, 2026Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY A CUSTOMER THAT WHEN THEY GENTLY SQUEEZED THE BURETTE TO INTRODUCE SALINE INTO THE CHAMBER, AT WHICH POINT THE BURETTE CRACKED VERTICALLY DOWN THE SIDE. NO EXCESSIVE FORCE WAS APPLIED; HOWEVER, THE BURETTE HAD NOT BEEN PULLING WELL FROM THE IVIG BOTTLES DURING THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974885 ↗
• MalfunctionApr 23, 2026Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY A CUSTOMER THAT A BURETTE WAS COMPLETELY FULL, BUT THE PUMP WAS NOT PULLING MEDICATION INTO THE LINE. THE TUBING RAN DRY AND PULLED AIR FROM JUST BELOW THE BURETTE UNTIL IT REACHED THE PUMP.

  Patient problems: Insufficient Information

  MAUDE report 24974884 ↗
• MalfunctionApr 23, 2026Crack; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT WHEN THEY GENTLY SQUEEZED THE BURETTE TO INTRODUCE SALINE INTO THE CHAMBER, AT WHICH POINT THE BURETTE CRACKED VERTICALLY DOWN THE SIDE. NO EXCESSIVE FORCE WAS APPLIED; HOWEVER, THE BURETTE HAD NOT BEEN PULLING WELL FROM THE IVIG BOTTLES DURING THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974882 ↗
• MalfunctionApr 21, 2026Crack; Leak/Splash

  IT WAS REPORTED, LEAKING BEGAN FROM THE FRONT OF THE BURETTE. A CRACK WAS NOTED ON THE FRONT OF THE CHAMBER.

  Patient problems: Insufficient Information

  MAUDE report 24944375 ↗
• MalfunctionApr 21, 2026Leak/Splash

  IT WAS REPORTED, LEAKING AT THE BOTTOM OF THE TUBING. THE LEAK APPEARED TO ORIGINATE FROM THE BASE OF THE CHAMBER, THOUGH THE EXACT SOURCE WAS DIFFICULT TO DETERMINE.

  Patient problems: Insufficient Information

  MAUDE report 24943417 ↗
• MalfunctionApr 7, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2441-0007 SET IV ADMINISTRATION PUMP MODULE ALARIS SMARTSITE 130IN BURETTE TUBING WAS LEAKING IN THE SOFT PART WHERE IT GOES IN THE CHANNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809380 ↗
• MalfunctionMar 20, 2026Backflow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING IS ALLOWING BLOOD FOR BACKUP THE LINE, AND ITS INTERFERING ON THE TREATMENT! PRODUCT: BD ALARIS¿ LVP BUR 60D SMBORE 3SS. REF#: 2441-0007. LOT#:25017418.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656450 ↗
• MalfunctionMar 20, 2026Backflow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING IS ALLOWING BLOOD FOR BACKUP THE LINE, AND ITS INTERFERING ON THE TREATMENT! PRODUCT: BD ALARIS¿ LVP BUR 60D SMBORE 3SS REF#: 2441-0007, LOT#:25017418.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656446 ↗
• MalfunctionJan 15, 2026Infusion or Flow Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082045 ↗
• MalfunctionJan 2, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TPN TUBING LEAKING ABOVE BURETROL. LEAK APPEARS TO BE NEAR THE VENTING TUBING THAT IS BELOW THE SPIKE. LOT# OF DEFECTIVE ITEM AVAILABLE: NO. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WAS THERE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THIS EVENT? NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952606 ↗
• MalfunctionNov 21, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  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 THE CUSTOMER THAT TPN LINE SUDDENLY DETACHED FROM THE TOP OF BURETROL CAUSING TPN TO GO EVERYWHERE AND LINE HAVING TO BE DISCONNECTED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623734 ↗
• MalfunctionJun 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THERE ARE SMALL BROWN SPECS IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313117 ↗
• MalfunctionMay 23, 2025Disconnection; Separation Failure; Disconnection; Separation Failure

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION BURETTE SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY CUSTOMER THAT RN WAS ATTEMPTING TO GET AIR OUT THE LINE AND THE SOFT PORTION OF THE TUBING THAT GOES IN THE PUMP, BROKE APART FROM THE BLUE HARD PLASTIC PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077823 ↗
• MalfunctionMar 17, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION BURETTE SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE IV SOLUTION DID NOT DRIP INTO THE BOTTOM CHAMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619470 ↗
• MalfunctionFeb 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION BURETTE SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT TUBING FOR LIPIDS WITH BURETROL, SUCKING AIR INTO THE COMPARTMENT UNDER THE BURETROL. DIFFICULT TO PRIME LINE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324791 ↗
• MalfunctionJan 23, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION BURETTE SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE CLINICIANS WOULD SPIKE THE IV BAG BUT ¿NO FLUID¿ WOULD GO INTO THE BURETROL CHAMBER. ATTEMPTED TO SQUEEZE THE BURETROL CHAMBER AND THEY STILL COULD NOT GET ANY MEDICATION TO COME OUT OF THE IV BAG. THEY WERE ULTIMATELY ABLE TO GET IT WORK BY HANGING THE IV SET UPSIDE DOWN AND ¿BACKWARDS¿ FLUSHING THE IV SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223847 ↗
• MalfunctionJan 9, 2025Complete Blockage; Complete Blockage

  MATERIAL # 2441-0007, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE CLINICIANS WOULD SPIKE THE IV BAG BUT ¿NO FLUID¿ WOULD GO INTO THE BURETROL CHAMBER. ATTEMPTED TO SQUEEZE THE BURETROL CHAMBER AND THEY STILL COULD NOT GET ANY MEDICATION TO COME OUT OF THE IV BAG. THEY WERE ULTIMATELY ABLE TO GET IT WORK BY HANGING THE IV SET UPSIDE DOWN AND ¿BACKWARDS¿ FLUSHING THE IV SET. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BURETROLS ¿BAD BATCH¿ REF#(B)(4) MDS COMPLAINT - PLEASE NOTIFY MDS TEAM. THE CLINICIANS WOULD SPIKE THE IV BAG BUT ¿NO FLUID¿ WOULD GO INTO THE BURETROL CHAMBER. ATTEMPTED TO SQUEEZE THE BURETROL CHAMBER AND THEY STILL COULD NOT GET ANY MEDICATION TO COME OUT OF THE IV BAG. THEY WERE ULTIMATELY ABLE TO GET IT WORK BY HANGING THE IV SET UPSIDE DOWN AND ¿BACKWARDS¿ FLUSHING THE IV SET. THE CLINICIANS REPORTED THE ISSUE AND LOT NUMBER TO SUPPLY CHAIN, IT OCCURRED ABOUT A MONTH AGO AND IT HAS NOT HAPPENED AGAIN SINCE. CUSTOMER RESPONSE RECEIVED ON (B)(6) 2024. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT FOR THE INCIDENT IN THIS FORMAT DD-MMM-YYYY? FIRST FORMAL REPORT: (B)(6) 2024. SECOND FORMAL REPORT: (B)(6) 2024. 2. PLEASE SHARE THE MAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120761 ↗
• MalfunctionJan 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION BURETTE SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM EMAIL SUMMARY INDICATED FOUR LEAKAGE EVENTS OBSERVED IN THE FACILITY FOR THE BD ALARIS BURETTE PUMP SET. AWAITING FURTHER DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092512 ↗