Alaris, SmartSite 2434-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07613203019682), received between Jul 2, 2019 and Feb 10, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 reports).

1 FDA recall record name this device's identifier, 1 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. Jul 8, 2025Class IOpen, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT ¿PUMP SAYING AIR IN LINE, OPENED PUMP TO TRY TO FLICK AIR UP. STRETCHY PART OF IV TUBING WAS LEAKING WITH A HOLE NOTED WHERE STRETCHY PART MEETS PROXIMAL/UPPER CONNECTION TO HARD TUBING. TUBING CLAMPED THEN DISCONNECTED FROM BABY. TPN BAG FLIPPED UPSIDE DOWN AND SECOND NURSE CAME TO TAKE BAG TO PRIME NEW TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351779 ↗
• MalfunctionNov 12, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT RN WAS ATTEMPTING TO HANG PATIENT'S OCREVUS WITH BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER REF #2434-0007, I WAS UNABLE TO PRIME TUBING WITH DRUG BEYOND FILTER. WHEN IT WAS PUT ON THE PUMP, THE PUMP KEPT SAYING OCCLUDED. CHANGED TUBING WAS ABLE TO INFUSE WITH NEW TUBING. NO LOT INFORMATION WAS SAVED/AVAILABLE. PRODUCT WAS NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663348 ↗
• MalfunctionNov 11, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20659759 ↗
• MalfunctionJun 11, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT HAS BEEN BROUGHT TO MY ATTENTION THAT IN A FEW SEPARATE OCCASIONS THE IV TUBING BELOW (REFERENCE # (B)(4)) WILL BEGIN PRIMING HOWEVER ONCE IT GETS TO THE FILTER IT WILL STOP.

  Patient problems: Insufficient Information

  MAUDE report 19510811 ↗
• MalfunctionJan 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MATERIAL#: 2434-0007. BATCH NUMBER#: 22035121. IT WAS REPORTED BY CUSTOMER THAT BD ALARIS PUMP INFUSION SET 0.2-MICRON FILTER FOR AMIODARONE THAT IS PROVIDED WILL NOT WORK FOR A 10-MINUTE IVPB BOLUS. THERE IS NO PORT ABOVE THE PUMP SEGMENT TO FLUSH WITH NORMAL SALINE AND THERE IS NO WAY TO CONNECT IT AS A SECONDARY. THE PT DID RECEIVE THE MEDICATION OVER 10 MINUTES WITHOUT A DELAY IN CARE. VERBATIM#: CAN YOU PLEASE TELL ME WHAT PRODUCT LOT #(10)22035121 WOULD BE ASSOCIATE WITH? I GOT A PRODUCT CONCERN WITHOUT THE MANUFACTURE NUMBER. IN THE COMMENTS IT SAYS THERE IS NO PORT ABOVE THE PUMP SEGMENT TO FLUSH WITH NORMAL SALINE AND THERE IS NO WAY TO CONNECT IT AS A SECONDARY. SUPPLY CHAIN AT THE SITE SAYS THERE APPEARS TO HAVE BEEN A CHANGE IN THE TUBING AND WHERE THE FILTER IS LOCATED????? THEY WERE USING THE PRODUCT TO INFUSE AMIODARONE. (B)(6) 2023. INTERNAL ID:(B)(4). EMERGENCY DEPARTMENT. NO HARM. PRODUCT SAVED: NO. DESCRIPTION: THE BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER FOR AMIODARONE THAT IS PROVIDED WILL NOT WORK FOR A 10 MINUTE IVPB BOLUS. THERE IS NO PORT ABOVE THE PUMP SEGMENT TO FLUSH WITH NORMAL SALINE AND THERE IS NO WAY TO CONNECT IT AS A SECONDARY. THIS PT DID RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423407 ↗
• MalfunctionOct 9, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD ALARIS¿ LVP 20D SS 0.2M CV THE TUBING WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN ISSUE EXPERIENCED HERE AT (B)(6) HOSPITAL .WITH AN ALARIS PUMP INFUSION SET REF 2434-0007. ALARIS PUMP INFUSION SET WAS DEFECTIVE. LINE WAS SPIKED, BUT TUBE WAS NOT ALLOWING MEDICATION TO FLOW.

  Patient problems: Insufficient Information

  MAUDE report 17900980 ↗
• MalfunctionMar 31, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS¿ LVP 20D SS 0.2M CV THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 3/7/23 TPN TUBING REMOVED FROM PACKAGE AND FOUND TO BE DISCONNECTED AT AN ACCESS SITE. NO HARM TO PATIENT. ITEM WAS SAVED FOR INVESTIGATION. REFERENCE NUMBER ON PACKAGE 2434-0007. LOT # (10)22035121.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660577 ↗
• MalfunctionMar 31, 2023Disconnection; Disconnection

  IT WAS REPORTED WHILE USING BD ALARIS¿ LVP 20D SS 0.2M CV DISCONNECTION OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 3/7/23 TPN TUBING REMOVED FROM PACKAGE AND FOUND TO BE DISCONNECTED AT AN ACCESS SITE. NO HARM TO PATIENT. ITEM WAS SAVED FOR INVESTIGATION. REFERENCE NUMBER ON PACKAGE 2434-0007. LOT # (10)22035121.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659976 ↗
• MalfunctionMar 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13872103 ↗
• MalfunctionMar 23, 2022Crack; Crack

  IT WAS REPORTED WHEN USING THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET, THE DEVICE EXPERIENCED CRACKS AND MICROCHANNEL ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING FILTER WAS CRACKED. IT WAS REPORTED BY THE CUSTOMER THAT THE LIPID LINE BROKE WHERE THE FILTER IS. TPN TUBING FILTER FOUND TO BE CRACKED LIPID LINE BROKE AT POINT WHERE FILTER IS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871354 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED WHEN USING THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET, THE DEVICE EXPERIENCED RUPTURED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING LEAKED. THE LIPID LINE BROKE WHERE THE FILTER IS. I AM TOLD THIS IS A IS AN ONGOING ISSUE AND UNITS ARE CONSISTENTLY SEEING DEFECTIVE PRODUCT. SPIKED NEW BAG FOUND LEAK IN TUBING INSIDE PUMP AT TOP OF STRETCHY AREA OF IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871339 ↗
• MalfunctionMar 23, 2022Complete Blockage; Failure to Infuse; Complete Blockage; Failure to Infuse

  IT WAS REPORTED WHEN USING THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET, THE DEVICE EXPERIENCED FLOW ISSUES DUE TO BEING OCCLUDED/CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING BEEPS OCCLUDED AND LIPIDS ARE GETTING CLOGGED. IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING BEEPS OCCLUDED AND UNABLE TO FREE FLOW LIPIDS THROUGH THE TUBING. IT WAS REPORTED BY THE CUSTOMER THAT LIPIDS WERE BEEPING OCCLUDED ON THE PUMP. NO FLOW WAS NOTED DESPITE SQUEEZING THE BAG. IT WAS REPORTED BY THE CUSTOMER THAT THE LIPID LINES WERE BEEPING OCCLUDED. THERE WAS NO FLOW WHILE UNCLAMPED DESPITE SQUEEZING THE BAG. LIPID TUBING CONTINUES TO BEEP OCCLUDED, LIPIDS ARE GETTING CLOGGED IN TUBING. LIPID TUBING BEEPS OCCLUDED AND UNABLE TO FREE FLOW LIPIDS THROUGH TUBING. LIPIDS WERE BEEPING OCCLUDED ON THE PUMP. THIS RN FLUSHED LINE, CHECKED CONNECTIONS ETC. TOOK TUBING OFF OF PUMP, NO FLOW WAS NOTED DESPITE SQUEEZING BAG. THIS RN WAS CALLED TO BEDSIDE BECAUSE LIPIDS LINE RUNNING THROUGH PICC WAS BEEPING OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871105 ↗
• MalfunctionFeb 17, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD ALARIS¿ LVP 20D SS 0.2M CV ONE OF THE PRODUCT WAS CRACKED AND BROKEN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2434-0007 BATCH/LOT #: UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THE PN TUBING FILTER FOUND TO BE CRACKED. VERBATIM: ISD-2434-0007-PN TUBING FILTER FOUND TO BE CRACKED-PN TUBING FILTER WAS FOUND TO HAVE A VISIBLE CRACK AT LAST ASSESSMENT BY DAYSHIFT RN. FILTER NOT LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552248 ↗
• MalfunctionFeb 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET BREAKS APART AND LEAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "BEING DEFECTIVE. EITHER BREAKING APART OR LEAKING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476785 ↗
• MalfunctionJan 28, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PRIMING IV TUBING FOR A LINE CHANGE, TPN STARTED SQUIRTING OUT OF THE FILTER OF THE IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387411 ↗
• MalfunctionJan 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS DAMAGED, RESULTING IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN CHECKING THE TUBING THERE WAS AIR IN THE FILTER. THE LINE/FILTER WAS CRACKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177703 ↗
• MalfunctionDec 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET EXPERIENCED DEVICE DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV FILTER TUBING HAD A SMALL CRACK IN IT CAUSING IV FLUID TO SLOWLY LEAK OUT AND BLOOD TO BACK UP IN THE PICC LINE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044437 ↗
• MalfunctionDec 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD ALARIS¿ PUMP MODULE ADMINISTRATION SETS THE TUBING SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE TUBING CAME APART WHILE INFUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13028633 ↗
• MalfunctionDec 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SECONDARY SET C61 EXPERIENCED DEVICE DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TPN FILTER TUBING LEAKING AT FILTER SITE. NOTICED THE LEAKING WHILE PRIMING THE IV FLUID. TUBING REMOVED FROM SERVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907938 ↗
• MalfunctionNov 18, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET LEAKED. "IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING WAS LEAKING DUE TO A SMALL FRACTURE AT THE Y SITE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839482 ↗
• MalfunctionOct 25, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET SCREW CAP FELL OFF INTO THE NURSE'S HAND WHEN DISCONNECTING THE TUBING FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A GREEN CUROS CAP WAS ATTACHED TO THE END OF THE TPN TUBING UPON DISCONNECTING THIS TUBING FROM THE PATIENT. UPON DOING SO, THE SCREW CAP THAT THE CUROS CAP SCREWS IN TO FELL OFF INTO THE RNS HAND. NEW TPN TUBING HAD TO BE OPENED AND HUNG WITH THE BAG OF TPN. NO PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693065 ↗
• MalfunctionOct 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET LEAKED FROM THE TPN TUBING AND FILTER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON 0500 ASSESSMENT OF PICC LINE, TPN TUBING WAS REPORTED TO BE LEAKING BY THE PATIENT. TPN FILTER NOTED TO BE INTERMITTENTLY LEAKING SMALL AMOUNTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586903 ↗
• MalfunctionOct 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET LEAKED FROM THE FILTER WHILE PRIMING THE TPN TUBING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE PRIMING THE TPN TUBING, I NOTICED DRIPPING. THE FLUID HASN¿T REACHED THE TIP OF THE TUBING BUT IS DRIPPING ALREADY SO I EXAMINED THE SET UP AND FOUND THERE WAS LEAKING ON THE END OF THE FILTER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586835 ↗
• MalfunctionFeb 25, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AS LVP 20D SS 0.2M CV LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2434-0007 BATCH NO: UNKNOWN. IT WAS REPORTED THAT WHILE PRIMING IV TUBING, A LEAK WAS NOTED FROM A CRACK IN THE FILTER. VERBATIM: 1. (B)(6) 2021, 16:20. 2. #2434-0007 ¿ NO LOT NUMBER PROVIDED. 3. ¿PRIMED IV TUBING AND NOTED LEAKING FROM A CRACK IN THE FILTER.¿ ¿ ITEM WAS KEPT AND WE CAN RETURN TO BD FOR INVESTIGATION. 4. PATIENT ¿ MALE, DOB (B)(6) 2020. ¿PRIMED IV TUBING AND NOTED LEAKING FROM A CRACK IN THE FILTER.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11378632 ↗
• MalfunctionFeb 17, 2021Leak/Splash

  IT WAS REPORTED THAT AS LVP 20D SS 0.2M CV WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2434-0007 BATCH NO: UNKNOWN/ IT WAS REPORTED THAT THERE ARE CRACKS IN THE CONNECTION PORT OF THIS ITEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11339291 ↗