Alaris, SmartSite 10010453Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 07613203021135), received between Oct 16, 2018 and Sep 16, 2026 — classified as 2 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (78 reports).

4 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. 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 ↗

3. 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 ↗

4. May 6, 2019Class ITerminated

   An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

   Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50795932 ↗
• MalfunctionSep 14, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765257 ↗
• MalfunctionFeb 9, 2026Complete Blockage; Obstruction 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 CUSTOMER THAT SEEMS AS THOUGH FILTER WAS SOMEWHAT BLOCKED IN FAULTY LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298552 ↗
• MalfunctionFeb 2, 2026Leak/Splash

  SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240337 ↗
• MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD DAMAGED / DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON INFUSING A TPN FOR 2 SEPARATE PATIENTS ON 10/27 AND 10/28, THE TUBING RIPPED OPEN NEAR THE BLUE FILTER PORTION, ALLOWING MEDICATION TO LEAK OUT AND BLOOD RETURN BACK TO THE TUBING. IN BOTH CASES, THE TUBING WAS EXCHANGED. DIFFERENT NURSES ADMINISTERED THE MEDICATION FOR BOTH PATIENTS, SO THE TUBING SETS APPEARED TO BE FAULTY. THE AFFECTED LOT WAS REMOVED FROM STOCK AND WILL NOT BE USED FOR PATIENT CARE. THIS IMPACTED PATIENT CARE AS PATIENT'S TPNS WERE STOPPED AND NOT FULLY ADMINISTERED, IMPACTING PATIENT NUTRITION AND MEDICATION ADMINISTRATION. PRODUCT CODE: 10010453.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624833 ↗
• MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD DAMAGED / DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON INFUSING A TPN FOR 2 SEPARATE PATIENTS ON (B)(6), THE TUBING RIPPED OPEN NEAR THE BLUE FILTER PORTION, ALLOWING MEDICATION TO LEAK OUT AND BLOOD RETURN BACK TO THE TUBING. IN BOTH CASES, THE TUBING WAS EXCHANGED. DIFFERENT NURSES ADMINISTERED THE MEDICATION FOR BOTH PATIENTS, SO THE TUBING SETS APPEARED TO BE FAULTY. THE AFFECTED LOT WAS REMOVED FROM STOCK AND WILL NOT BE USED FOR PATIENT CARE. THIS IMPACTED PATIENT CARE AS PATIENT'S TPNS WERE STOPPED AND NOT FULLY ADMINISTERED, IMPACTING PATIENT NUTRITION AND MEDICATION ADMINISTRATION. PRODUCT CODE: 10010453.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623641 ↗
• MalfunctionJul 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOT SURE SOURCE OF LEAK WITH ALL 3 PRODUCTS. POST CHEMO ADMINISTRATION, CHEMO LINE WAS NOTICED TO BE WET AROUND THE FILTER PART OF THE TUBING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT MEDICATION WAS BEING ADMINISTERED AND LEAKED? CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561203 ↗
• MalfunctionJul 21, 2025Complete Blockage; Complete Blockage

  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 THE CUSTOMER THAT THE END USER IS NOTING THAT WHEN ATTEMPTING TO PRIME THE INFUSION SET FOR TPN ADMINISTRATION, THEY ARE UNABLE TO PRIME PAST THE FILTER LOCATION. A SECOND INFUSION SET WITH THE SAME LOT NUMBER WAS USED AND AGAIN THEY WERE UNABLE TO PRIME THE LINE PAST THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559679 ↗
• MalfunctionJun 27, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM 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 THE TUBING WAS LEAKING AND LIPIDS WERE POKING OUT UNDER THE BLUE PART.

  Patient problems: Swelling/ Edema

  MAUDE report 22346407 ↗
• MalfunctionJun 25, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325441 ↗
• MalfunctionDec 11, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 10010453. BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT TPN LEAKED OUT RIGHT ABOVE FILTER (OCCURRED WITH IV SET WITH INLINE FILTER REF# 10010453). NO FURTHER DETAILS AVAILABLE AT TIME OF INTERVIEW. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. ¿ EVENT WHERE TPN LEAKED OUT RIGHT ABOVE FILTER (OCCURRED WITH IV SET WITH INLINE FILTER REF# 10010453). NO FURTHER DETAILS AVAILABLE AT TIME OF INTERVIEW.

  Patient problems: Insufficient Information

  MAUDE report 20902187 ↗
• MalfunctionSep 16, 2024Infusion or Flow Problem; Infusion or Flow Problem

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233703 ↗
• MalfunctionJan 30, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: (B)(4)- LIPID TUBING BROKE. BLOOD BACK UP AND LIPIDS LEAKED ON BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609853 ↗
• MalfunctionDec 3, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE HAVE HAD AN ISSUE RAISED AT MUMC IN REGARDS TO THERE APPEARING TO BE CONNECTION ISSUES BETWEEN THE BD ALARIS TUBING AND MC100 CLAVE. MUMC IS SAYING THEY BELIEVE THAT THIS HAS LED TO A CENTRAL LINE INFECTION WHEN USING MC100 WITH 10010453 AND 2432-0007, THEY ARE NOTICING THE CONNECTIONS ARE NOT STAYING TIGHT WITH IT ¿FALLING APART¿, WHICH IS NEW AS ALL THREE CODES ARE USED WIDELY ACROSS OUR SITES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253763 ↗
• MalfunctionNov 20, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170540 ↗
• MalfunctionNov 11, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): ON (B((6) 2023. SITE NAME/LOCATION: (B)(6) HOSPITAL. LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: SMOF LIPIDS HELD FOR ADMINISTRATION OF PIP-TAZ ANTIBIOTIC. PAUSED ON ALARIS PUMP. AFTER FIRST DOSE WAS GIVEN WITH NO ISSUES, AFTER SECOND DOSE OF ANTIBIOTIC IN DAY SHIFT, APPROXIMATELY 20MINUTES AFTER RE-STARTING SMOF, PUMP RANG OFF OCCLUDED PATIENT SIDE. UPON TROUBLE-SHOOTING LINE, ALARIS TUBING OF SMOF, NO LONGER ABLE TO RUN ANY VOLUME THROUGH OR PULL ANY VOLUME THROUGH PAST FILTER PORTION CLOSEST TO PATIENT. TUBING HAD TO BE CHANGED. IMPACT OF INCIDENT: NO EVIDENT CONCERN . WHO WAS AFFECTED? PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117213 ↗
• MalfunctionOct 11, 2023Leak/Splash; Leak/Splash

  MAT#: 10010453. BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT BD ALARIS IV TUBING BREAK APART AT THE FILTER LEADING TO THE CENTRAL LINE BEING OPEN. VERBATIM: IN THE NICU, WE HAD A BD ALARIS IV TUBING BREAK APART AT THE FILTER LEADING TO THE CENTRAL LINE BEING OPEN (IREPORT (B)(4)). THE REFERENCE NUMBER IS (B)(4). PREMIER NUMBER IS (B)(4). COULD YOU PLEASE GIVE ME WHAT THE NEXT STEPS ARE FOR SUBMITTING THE TUBING TO THE REP FOR INSPECTION? ON 06OCT2023. LOT NUMBER: UNKNOWN. WAS THERE ANY LEAKAGE WHEN THIS EVENT OCCURRED? YES BECAUSE THE TUBING CAME APART. WAS THERE ANY PATIENT INVOLVEMENT? YES. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. WHAT WAS THE PATIENT OUTCOME? THE CENTRAL LINE WAS REMOVED. WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? YES. WHAT PROCEDURE WAS BEING PERFORMED? N/A. WHAT MEDICATION WAS USED IN THE PROCEDURE? N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17917419 ↗
• MalfunctionOct 3, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT WHILE USING THE BD ALARIS¿ LVP 20D LOW SORB SS 1.2M THERE IS AIR IN THE LINE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE RN IS ATTACHING THIS TUBING TO THE CLINIMIX E TPN FOMULATION AND PRIMING THE LINE AND HANGING ON AN ALARIS PUMP. BUT AFTER A FEW HOURS, TINY CHAMPAGNE BUBBLES START TO FORM IN THE BAG AND SET THE PUMP ALARMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865003 ↗
• MalfunctionAug 1, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET THE DEVICE WAS DIFFICULT TO DISCONNECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REQUESTING A COPY OF THE IFU FOR ALARIS TUBING SET 10010453. CALLER STATES SHE WANTS TO SEE IF THE IFU FOR THE SET ADDRESSES SET CHANGE INTERVAL RECOMMENDATIONS. CALLER STATES SOMETIMES IT IS DIFFICULT FOR THE CLINICIANS TO DISCONNECT THIS TUBING SET FROM THE CONNECTION.

  Patient problems: Insufficient Information

  MAUDE report 17436003 ↗
• MalfunctionJul 28, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT 2 OF THE BD ALARIS¿ LVP 20D LOW SORB SS 1.2M EXPERIENCED UNDER INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED WHEN HANGING NIGHTLY IV LIPIDS, THE 1.2-MICRON FILTER WAS NOT FILLING ALL THE WAY / FINISHING PRIMING (WITH 2 DIFFERENT SETS OF IV TUBING). WHEN WRITER NOTIFIED PHARMACY, WRITER WAS TOLD THAT CERTAIN FILTERS HAVEN'T BEEN WORKING CORRECTLY LATELY. IT SEEMED TO BE THE IV TUBING SETS WITH LOT # (10)22125416.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17418829 ↗
• MalfunctionJul 7, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP 20D LOW SORB SS 1.2M HAD A TINY HOLE IN THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCOUNT STATES TINY HOLE IN #10010453 TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283419 ↗
• MalfunctionJul 6, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ LVP 20D LOW SORB SS 1.2M A HOLE WAS DISCOVERED IN TUBING AND LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A NURSE REPORTED A TINY HOLE IN THE IV TUBING IN USE ON A PATIENT, WHEN THE SOLUTION WAS FOUND TO BE LEAKING OUT AFTER THE INFUSION RUNNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276173 ↗
• MalfunctionJun 29, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET IS OCCLUDED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: (1) CLOGGED LIPID LINE DATE OF EVENT: 15-MAY-2023.

  Patient problems: Insufficient Information

  MAUDE report 17234721 ↗
• MalfunctionJun 29, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 2 OF THE BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET IS OCCLUDED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PREVIOUS ISSUES INCLUDE LIPIDS NOT PRIMING THROUGH THE FILTER, THEREFORE THEY HAD TO WASTE LIPIDS BY CHANGING OUT THE LINE.

  Patient problems: Insufficient Information

  MAUDE report 17234719 ↗
• MalfunctionJun 29, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE WITH BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET AIR WAS DISCOVERED IN LINE JUST AS IT WAS REACHING PATIENT, ALARM WAS NOT SOUNDING. INFORMATION ABOUT POTENTIAL PATIENT IMPACT HAS NOT BEEN RECEIVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿I NEED HELP WITH GETTING A HOLD OF A REPRESENTATIVE THAT CAN DO SOME TESTING OF A LINE AND FILTER. THIS IS FOR A BD ALARIS PUMP INFUSION SET 1.2-MICRON FILTER REF (B)(4). THAT HAD AIR IN THE LINE BELOW THE FILTER. THE IN THE LINE WAS NOTED BY THE BEDSIDE RN, JUST AS IT WAS REACHING THE PATIENT. THE ALARM FROM THE PUMP WAS NOT SOUNDING (THIS WAS SEQUESTERED). WE WANT TO SEE IF THERE WAS SOMETHING WRONG WITH THE LINE OR FILTER.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234686 ↗