Alaris, SmartSite 11532269Recalls & reported problems

Summary

The FDA's MAUDE database contains 332 adverse event reports that list this exact device (DI 10885403232343), received between Aug 1, 2018 and Sep 29, 2026 — classified as 6 injuries, 325 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (183 reports).

3 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 19, 2026Open, 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 · FDA record ↗

2. Jul 8, 2025Open, 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 · FDA record ↗

3. Oct 11, 2023Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 332 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936980 ↗
• MalfunctionSep 22, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860024 ↗
• MalfunctionSep 11, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744351 ↗
• MalfunctionAug 26, 2026Break; Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462634 ↗
• MalfunctionAug 26, 2026Break; Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462619 ↗
• MalfunctionJun 16, 2026Leak/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 VERBATIM IT WAS REPORTED BY CUSTOMER THAT AADS ALARIS IN-LINE FILTER LEAKING AT SHIFT ONSET. AADS INFUSION STOPPED, REPLACED WITH NEW MAINTENANCE INFUSION AND ALARIS TUBING. AADS BAG AND TUBING KEPT AND PLACED IN NICU DIRTY UTILITY ROOM FOR NICU EDUCATORS TO ASSESS. OF NOTE, LINE WAS JUST CHANGED 1-2 HOURS PRIOR TO LEAKING FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526689 ↗
• MalfunctionJun 16, 2026Leak/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 VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT AADS FILTER NOTED TO BE STICKER WHEN LINE CHECKED. FILTER CLEANSED AND STICKINESS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25525215 ↗
• MalfunctionJun 15, 2026Leak/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 VERBATIM: IT WAS REPORTED BY CUSTOMER THAT INLINE FILTER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511622 ↗
• MalfunctionJun 11, 2026Material Separation; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN IV TUBING CONNECTOR DISCONNECTED WHILE AN RN WAS ADDRESSING AN AIR-IN-LINE ALARM. THE LINE WAS CLAMPED, REPLACED, AND THE INFUSION CONTINUED WITHOUT AFFECTING PATIENT CARE; THE EQUIPMENT WAS RETAINED FOR INVESTIGATION. CAT# OF PRODUCT BEING COMPLAINED: (B)(6). DESCRIPTION OF PRODUCT: SET CHECK VALVE 0.2MIC 2NF 87/6IN 2PC MALE L/L (B)(4) EA/CA LOT OR S/N: UNKNOWN COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME PATIENT INJURY: NO QTY AFFECTED: (B)(4) EA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474092 ↗
• MalfunctionMay 28, 2026Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT COMPLETED STERILE LINE CHANGE WITH 2 RNS PRESENT PER UNIT POLICY FOR CENTRAL LINE. ONCE TPN WAS RUNNING ON PUMP, RN NOTICED FLUID DRIPPING ONTO FLOOR. WHEN LINE WAS TRACED, RN FOUND THAT AT ONE OF THE JUNCTIONS ON THE LINE HAD A PINHOLE LEAK CAUSING TPN TO LEAK OUT AND AIR TO GET INTO LINE BREAKING STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321885 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING DETACHED FROM THE POINT OF ATTACHMENT ON THE FILTER. INJURIES OR ADVERSE EVENT: NO. ITEM: 11532269. QUANTITY AFFECTED:1 EACH. SERIAL/LOT NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291686 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING DETACHED FROM THE POINT OF ATTACHMENT ON THE FILTER. INJURIES OR ADVERSE EVENT: NO. ITEM: 11532269. QUANTITY AFFECTED:1 EACH. SERIAL/LOT NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291656 ↗
• MalfunctionMay 20, 2026Separation 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 WHILE TRYING TO GET AIR OUT OF THE LINE WHILE IT WAS IN THE PUMP THE TUBING TOTALLY DISCONNECTED AND SPILLED TPN EVERYWHERE. WE HAD TO BREAK IN TO THE LINE AGAIN ON A PICC TO REPLACE THIS WHOLE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231979 ↗
• MalfunctionMay 8, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CHEMOTHERAPY IV TUBING LEAKED FROM THE FILTER. IN THIS CASE IT WAS ON THE BEDDING BUT DID NOT TOUCH OR BURN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130984 ↗
• MalfunctionMay 8, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 24-HOUR CHEMOTHERAPY LEAKED FROM THE FILTER IN THE LVP 20D LOW SORB 2SS 0.2MICRON CV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130866 ↗
• MalfunctionMay 8, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CHEMOTHERAPY IV TUBING LEAKED FROM THE FILTER. IN THIS CASE, THE CHEMOTHERAPY DRIPPED ONTO THE PATIENT CAUSING A MINOR BURN.

  Patient problems: Burn(s)

  MAUDE report 25130863 ↗
• MalfunctionMay 7, 2026Crack; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116209 ↗
• MalfunctionMay 7, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING OR AFTER PRIMING A PATIENT'S MEDICATION, NURSES OBSERVED LEAKAGE CAUSED BY A BROKEN TUBE. IN MOST CASES, THE TUBING EITHER SNAPPED WHILE INSERTED IN THE ALARIS PUMP OR THE ENDS OF THE TUBING WERE FOUND TO BE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116172 ↗
• MalfunctionApr 29, 2026Product Quality Problem; Separation Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES.THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM.IT WAS REPORTED BY CUSTOMER THAT BROKE WHEN SHE PRIMED THE NEW LINE WITH A NEW BAG OF AMIODARONE; THE PART OF THE LINE ATTACHED TO THE DISTAL (PATIENT SIDE) PORT OF THE FILTER DETACHED WHILE PRIMING THE LINE; THE NURSE NOTICED BLOOD BACK FLOWED INTO THE LINE AND THE LINE WAS DISCONNECTED AT THE DISTAL END (THE PATIENT SIDE) OF THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028838 ↗
• MalfunctionApr 28, 2026Separation 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 CUSTOMER THAT BROKE WHEN SHE PRIMED THE NEW LINE WITH A NEW BAG OF AMIODARONE; THE PART OF THE LINE ATTACHED TO THE DISTAL (PATIENT SIDE) PORT OF THE FILTER DETACHED WHILE PRIMING THE LINE; THE NURSE NOTICED BLOOD BACK FLOWED INTO THE LINE AND THE LINE WAS DISCONNECTED AT THE DISTAL END (THE PATIENT SIDE) OF THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021735 ↗
• MalfunctionApr 28, 2026Separation Problem

  ADDITIONAL INFORMATION: THIS IS THE SECOND TIME THIS HAPPENED THIS SHIFT WITH THE BD ALARIS PUMP INFUSION SET 0.2 MICRON FILTER LOW SORBING TUBING PRIMED WITH AMIODARONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021691 ↗
• MalfunctionApr 28, 2026Separation 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 . IT WAS REPORTED BY CUSTOMER THAT BROKE WHEN SHE PRIMED THE NEW LINE WITH A NEW BAG OF AMIODARONE; THE PART OF THE LINE ATTACHED TO THE DISTAL (PATIENT SIDE) PORT OF THE FILTER DETACHED WHILE PRIMING THE LINE; THE NURSE NOTICED BLOOD BACK FLOWED INTO THE LINE AND THE LINE WAS DISCONNECTED AT THE DISTAL END (THE PATIENT SIDE) OF THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021151 ↗
• MalfunctionApr 24, 2026Fluid/Blood Leak

  IT WAS REPORTED, IV TUBING LEAKING IV FLUIDS DESPITE ROLLER CLAMP BEING CLAMPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983550 ↗
• MalfunctionApr 17, 2026Break; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24911040 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897424 ↗