Alaris, SmartSite 11426965Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10885403232558), received between Jan 17, 2019 and Sep 24, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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. 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889795 ↗
• MalfunctionAug 28, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506868 ↗
• MalfunctionAug 13, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237317 ↗
• MalfunctionMay 22, 2026Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I DO HAVE A SEPARATE INCIDENT I WOULD LIKE TO DOCUMENT, THOUGH. A SIMILAR OCCURRENCE WITH LOT (10)26025019. PHOTO IS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255783 ↗
• MalfunctionFeb 20, 2026Leak/Splash

  SET LEAKING AT CHECK VALVE NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402226 ↗
• MalfunctionFeb 12, 2026Leak/Splash

  IT WAS REPORTED LEAKAGE. DESCRIPTION: THE RNS HAD STARTED THE ALBUMIN INFUSION TO RUN SECONDARY IN THEY-SITE ABOVE THE PUMP. ALL CONNECTIONS WERE SECURE AND WHEN THEY WENT BACK IN LATER, THERE WAS A PUDDLE ON THE FLOOR. THE FLUSHED THE TOP Y-SITE JUST UNDER THE PUMP AND IT LEAKED OUT OF THE MIDDLE Y-SITE AROUND THE GREEN CUROS CAP. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328417 ↗
• MalfunctionDec 8, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742081 ↗
• MalfunctionDec 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT LEAKAGE FROM THE ALARIS TUBINGS WHEN GIVING DEXAMETHASONE IV PUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722223 ↗
• MalfunctionJul 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING IS DETACHED AT THE TOP OF THE PUMP SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487838 ↗
• MalfunctionSep 23, 2024Complete Blockage; Complete Blockage

  ADDITIONAL INFO FROM CUSTOMER: 1. IMPACT TO PT.- DELAY IN RECEIVING MEDICATION. 2. NO SERIOUS INJURY OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280477 ↗
• MalfunctionSep 5, 2024Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: 1) PLEASE CONFIRM WHETHER THE LEAKAGE WAS OBSERVED IN THE TUBING OR SMARTSITE PORT? SMARTSITE PORT 2) PLEASE CONFIRM IF ANY PHYSICAL DAMAGE OR DEFORMITY WAS OBSERVED TO THE PRODUCT? NONE THAT THE RN OBSERVED. 3) PLEASE CONFIRM IF THE LEAKAGE WAS IDENTIFIED DURING PRIMING OR DURING INFUSION? IF DURING INFUSION, HOW LONG INTO THE INFUSION? THE SALINE WAS NOTICED AT THE END OF THE INFUSION AS A PUDDLE ON THE FLOOR. THE PRE-HYDRATION IS A 30-MINUTE INFUSION. 4) PLEASE CONFIRM THE SEQUENCE OF EVENTS UNTIL THE LEAKAGE OCCURRED. RN PRIMED SALINE IN ROOM ATTACHED TO ALARIS PUMP AND DID NOT NOTICE OBVIOUS LEAKS IN REAL TIME ONLY NOTICED AT THE END WITH THE FLUID ON THE FLOOR. 5) PLEASE CONFIRM WHAT WAS BEING INFUSED. NORMAL SALINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20151646 ↗
• MalfunctionMar 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM GOOD AFTERNOON. ON 2/29/2024, WE HAD A SAFETY EVENT REPORTED FOR BD ITEM # 11426965 (BD ALARIS PUMP TUBING). LET¿S IDENTIFY THIS AS BD 265, AS A REFERENCE NUMBER. THE DEFECTIVE PRODUCT HAS BEEN DISCARDED BY THE CLINICIANS. BASED ON THE INFORMATION PROVIDED BELOW, COULD YOU START A PRODUCT QUALITY REPORT? EVENT DETAILS: ¿PRIOR TO STARTING DOCETAXEL - NOTED LEFT SIDE OF BED WAS SATURATED WITH CLEAR LIQUID INCLUDING PATIENT LEFT SLEEVE CLOTHING. IV SITE LEFT ANTECUBITAL - DRY AND INTACT, GOOD BLOOD RETURN. IV TUBING ASSESSED AND FOUND A LEAK FROM END OF TUBING CONNECTION AND LUER LOCK. UPON FURTHER INVESTIGATION A HAIRLINE CRACK WAS SEEN SCREW SIDE OF TUBING. PATIENT VERBALIZED SHE DIDN'T FEEL SLEEPY AFTER BENADRYL WAS GIVEN .IV SET UP CHANGED ENTIRELY. APRN WAS NOTIFIED - AND WAS INSTRUCTED TO RE-DOSE WITH ALL PRE MEDICATIONS - DEXAMETHASONE, BENADRYL, PEPCID AND ZOFRAN.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001791 ↗
• MalfunctionFeb 20, 2024Defective Device; Defective Device

  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 : PRIMARY 5-PORT IV TUBING WAS INSPECTED BY RN WHEN CHEMO WAS BEING CONNECTED TO THE PRIMARY LINE. RN NOTICED CRACK IN LUER LOCK CONNECTOR. TUBING WAS DISCONNECTED FROM PATIENT. NO PACKAGING WITH LOT # AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18740771 ↗
• MalfunctionFeb 20, 2024Crack; Crack

  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 PRIMARY 5-PORT IV TUBING WAS INSPECTED BY RN. RN NOTICED CRACK IN LUER LOCK CONNECTOR. TUBING DISCONNECTED FROM PATIENT. NO PACKAGING WITH LOT # AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740585 ↗
• MalfunctionFeb 16, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD AS LVP 20D CV - HAS A DAMAGED LUER AND SEPARATED AT THE CONNECTION TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING DISCONNECTED FROM PATIENT AND FOUND TO HAVE A PIECE OF THE LUER LOCK CONNECTOR BROKEN OFF. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT. NO PATIENT HARM IDENTIFIED AT THIS TIME. DID THE EVENT LEAD TO ANY LEAK/SPILL? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722304 ↗
• MalfunctionJan 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: EVENT DETAILS: ¿AFTER PRIMING IV TUBING WITH MEDICATION, THE MEDICATION WITH THE IV TUBING ATTACHED WAS BROUGHT TO THE PATIENT'S ROOM. WHEN GENTLY DETANGLING THE TUBING IN ORDER TO ATTACH TO THE PATIENT'S LINE, RN NOTICED THAT THE IV TUBING WAS COMPLETELY DETACHED IN ONE SPOT, SPILLING THE MEDICATION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545915 ↗
• MalfunctionSep 25, 2023Air/Gas in Device; Air/Gas in Device

  NO ADDITIONAL INFORMATION WAS PROVIDED MAT#: 11426965 LOT#:23015088 IT WAS REPORTED BY CUSTOMER THAT WHILE GIVING ROUTINE MEDICATIONS, CUSTOMER WAS ABOUT TO CONNECT A SHORT SET TO THE PATIENTS MAIN FLUID LINE. WHILE TRACING THE LINE, CUSTOMER NOTICED A SIGNIFICANT AMOUNT OF AIR IN THE TUBING BELOW THE PUMP. CUSTOMER ALSO NOTICED AIR BUBBLES APPEARING JUST AFTER ONE OF THE CONNECTING SITES. VERBATIM: AIR BUBBLES IN TUBING AND CONNECTION SITE HELLO BD TEAM, GOOD AFTERNOON. ON 08/26/2023, WE HAD A SAFETY EVENT REPORTED FOR BD ITEM # 11426965 (BD ALARIS PUMP INFUSION SET: BD ALARIS¿ LVP 20D CV). LET¿S IDENTIFY THIS AS BD 247, AS A REFERENCE NUMBER. THE DEFECTIVE PRODUCT IS AVAILABLE FOR PICK UP FROM DEFECT DEPOT. PLEASE CONTACT XXXXXXX (COPIED HERE) FOR ANY DEFECT DEPOT RELATED QUESTIONS. BASED ON THE INFORMATION PROVIDED BELOW, COULD YOU START A PRODUCT QUALITY REPORT? BD 247: REPORTED DATE: 08/26/2023; EVENT DATE: 08/26/2023; ITEM NUMBER: 11426965; LOT NUMBER: 23015088; ITEM RETAINED IN DEFECT DEPOT?: YES; PICTURE: YES, ATTACHED; PATIENT HARM: NO HARM; AREA: G9 ((B)(6) HOSPITAL) EVENT DETAILS: ¿WHILE GIVING ROUTINE MEDICATIONS, I WAS ABOUT TO CONNECT A SHORT SET TO THE PATIENTS MAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814739 ↗
• MalfunctionJun 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET THE TUBING IS KINKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 11426965 COMING KINKED & TANGLED RIGHT OUT OF PACKAGE/SEVERAL OCCASIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243713 ↗
• MalfunctionJun 29, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET THE TUBING IS KNOTTING AND HAS CAUSED DELAYS IN SURGERY SO THE KNOTS CAN BE REMOVED. THIS HAS BEEN OCCURRING SEVERAL TIMES FOR AN EXTENDED AMOUNT OF TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED, THEY HAD ENCOUNTERED KNOTTING WITH THE PRIMARY IV TUBING. CUSTOMER ASKING HAS THERE BEEN A CHANGE TO THE TUBING OR THE PACKAGING? THE STAFF SAY THE TUBING SEEMS LONGER. FURTHERMORE, ONE OF THE NURSES SAY THAT IF YOU DON¿T PULL IT OUT OF THE PACKAGING IN SUCH A MANNER THAT IT WILL EASILY KNOT. ADDITIONAL INFORMATION OBTAINED FROM CUSTOMER: DID THE EVENT INTERRUPT TREATMENT, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN TREATMENT, THAT NEGATIVELY IMPACTED THE PATIENT? IF YES, PLEASE PROVIDE DETAILS. YES, SURGERY HAS BEEN DELAYED DUE TO THE NEED TO REMOVE KNOTS IN TUBING WHEN PATIENT ARRIVES IN OR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234685 ↗
• MalfunctionApr 6, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET DISCONNECTED FROM THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICAL PRODUCTS ADVISOR OF THE HOSPITAL REPORTED THAT ONE OF THE ONCOLOGY 5 PORT LINES, THE SMARTSITE CONNECTOR DISCONNECTED FROM THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691482 ↗
• MalfunctionMar 18, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING BROKE AND DISCONNECTED ABOVE THE PUMPING SEGMENT, LEAKING IV FLUID AND MEDICATION ONTO THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING BROKE & DISCONNECTED/ LEAKAGE. PATIENT HAD AN IV MEDICATION INFUSING, WHEN THE TUBING BROKEN AND DISCONNECTED. THE BLUE PIECE ABOVE THE ELASTIC PUMPING SECTION, THAT GOES INTO THE ALARIS BRAIN, POPPED OFF AND IV FLUIDS AND MEDICATION WERE LEAKING ONTO THE FLOOR. NURSE STATED THIS ALSO HAPPENED LAST WEEK. UNSURE IF CORRECT LOT NUMBER, AS THIS TUBING WAS HUNG ON SUNDAY (B)(6), 2023."

  Patient problems: Chemical Exposure

  MAUDE report 16570331 ↗
• MalfunctionMar 18, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING BROKE AND DISCONNECTED ABOVE THE PUMPING SEGMENT, LEAKING IV FLUID AND MEDICATION ONTO THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING BROKE & DISCONNECTED/ LEAKAGE. ON (B)(6) 2023, WE HAD A SAFETY EVENT REPORTED FOR BD ITEM # 11426965. DURING THIS INCIDENT, THE TUBING BROKE AND WAS DISCONNECTED." PATIENT HAD AN IV MEDICATION INFUSING, WHEN THE TUBING BROKEN AND DISCONNECTED. THE BLUE PIECE ABOVE THE ELASTIC PUMPING SECTION, THAT GOES INTO THE ALARIS BRAIN, POPPED OFF AND IV FLUIDS AND MEDICATION WERE LEAKING ONTO THE FLOOR. NURSE STATED THIS ALSO HAPPENED LAST WEEK."

  Patient problems: Chemical Exposure

  MAUDE report 16570327 ↗
• MalfunctionJan 26, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE INFUSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV INFUSION SET WAS LEAKING FROM THE LOWEST PORT (CLOSEST TO THE PATIENT); PATIENT CALLED RN AND REPORTED THAT HER IV WAS "LEAKING" WHEN ARRIVING TO THE ROOM, THE BED SHEETS AND PART OF THE PATIENTS CLOTHES WERE VISIBLE WET. NO LEAKING WAS NOTED AROUND THE PORT SITE. CONNECTIONS WERE CHECKED AND WERE TIGHT. PATIENT HAD TWO TUBINGS CONNECTED VIA Y SITE. TUBING RUNNING NORMAL SALINE WAS ASSESSED AND IT WAS NOTED THAT THE LOWEST PORT (CLOSEST TO THE PATIENT) OF THE 5 PORT TUBING WAS LEAKING SALINE. A 10 ML NS SYRINGE WAS CONNECTED TO THE HIGHEST PORT AND WHEN IT WAS PUSHED, SALINE WOULD SHOOT OUT OF THE LOWEST PORT. ONLY SALINE WAS RUNNING THROUGH THE LINE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251442 ↗
• MalfunctionJan 12, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE INFUSION SET COMPONENTS SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THIS INCIDENT, THE IV INFUSION SET WAS DISCONNECTED FROM THE REST OF THE TUBING ABOVE THE LOADING CHAMBER OF ALARIS PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16152950 ↗
• MalfunctionNov 23, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BD (B)(6) PUMP MODULE (B)(6) INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLEASE OPEN A CASE REGARDING AN ISSUE WITH THE (B)(6) CONNECTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865310 ↗