Alaris, SmartSite, Texium 24301-0007TRecalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10885403223198), received between Aug 9, 2018 and Jun 19, 2026 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (39 reports).

4 FDA recall records name this device's identifier, 4 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. May 12, 2025Class IIOpen, Classified

   Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

   Z-1970-2025 · Root cause: Process control · Recall details · FDA record ↗

4. 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) LEAKING AT FILTER. LEAK WAS NOT IDENTIFIED UNTIL NURSING STARTED INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567744 ↗
• MalfunctionJan 25, 2026Leak/Splash

  IT IS REPORTED LEAKING. VERBATIM: CUSTOMER IN ONCOLOGY INFUSION HAD A LEAKING ISSUE THAT OCCURRED ON A PRIMARY TEXIUM TUBING (ITEM 24301-0007T) AT THE GREEN END CAP ATTACHED TO THE KVO LINE BELOW THE ALARIS PUMP. (LOT (10)25025373).

  Patient problems: Chemical Exposure

  MAUDE report 24175747 ↗
• MalfunctionDec 23, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP TEXIUM INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT WHEN THEY WENT TO TRY TO PUT THE DRUG INTO THE BAG USING THE CONNECTION SITE ON OUR FILTER TUBING AND WAS NOT ABLE TO GET THE DRUG TO LEAVE THE SYRINGE THAT WAY. SHE THEN USED A NEEDLE TO PUT THE DRUG THAT WAS IN THE SYRINGE INTO THE PATIENT'S BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877108 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBAITM IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A PINHOLE IN THE TUBING THAT CAUSED IT TO SQUIRT OUT OF THE TUBING AND ALL OVER HER SHIRT WHEN SHE WENT TO ADMINISTER IT.

  Patient problems: Chemical Exposure

  MAUDE report 22936040 ↗
• MalfunctionAug 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT HAZARDOUS DRUG LEAKING FROM TEXIUM AND SMARTSITE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887483 ↗
• MalfunctionAug 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT HAZARDOUS DRUG LEAKING FROM TEXIUM AND SMARTSITE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886584 ↗
• MalfunctionAug 12, 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 CUSTOMER THAT THE LEAKAGE IS OCCURING WHEN THE TEXIUM IS BEING USED IN TANDEM WITH THE IV LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22780016 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM, IT WAS REPORTED BY CUSTOMER THAT THE LINE COMPLETELY BROKE IN HALF AND SPILL WAS SIGNIFICANT ENOUGH FOR THEM TO HAVE TO SHOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22164955 ↗
• MalfunctionMay 29, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109368 ↗
• MalfunctionApr 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED: "PT CALLED OUT AND SAID THAT SHE WAS LEAKING. UPON ENTERING THE ROOM THE TUBING (TEXIUM) WAS LEAKING. INFUSION WAS STOPPED AND MEDICATION WAS TAKEN TO PHARMACY. PT TOUCHED THE TUBING AND WAS INSTRUCTED TO WASH HER HANDS WITH SOAP AND WATER. PHARMACY REPLACED THE TUBING AND INFUSION WAS RESTARTED AND FINISHED WITHOUT DIFFICULTY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763257 ↗
• MalfunctionMar 12, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED: ¿THE TUBING FILTER LEAKED WHILE BEING PRIMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590486 ↗
• MalfunctionFeb 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE ALARIS TUBING 24301-0007T IS LEAKING AT THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408034 ↗
• MalfunctionJan 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE TUBING FILTER LEAKED WHILE BEING PRIMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150043 ↗
• MalfunctionJan 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT TWO INSTANCES OF CHEMOTHERAPY TUBING THAT HAD A POSSIBLE LEAK AROUND THE 0.2 MICRON FILTER. THE LEAK WAS DESCRIBED AS A SMALL AMOUNT OF FLUID ON THE OUTSIDE OF THE FILTER, WHICH HIS NOT NEAR THE CONNECTION SITE TO THE PATIENT IV OR THE MEDICATION BAG. SINCE THIS HAPPENED TWICE IN 24 HOURS, WE ARE WONDERING IF THERE MIGHT BE AN ISSUE WITH THE LOT THAT WE HAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143827 ↗
• MalfunctionJan 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE RN NOTICED A LEAK FROM THE END OF THE BD ALARIS TEXIUM LOW SORB TUBING WITH 0.2 MICRON FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120759 ↗
• MalfunctionJan 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE BD ALARIS PUMP INFUSION SET TEXIUM LOW SORB TUBING WITH 0.2 MICRON FILTER HAD A LEAK.

  Patient problems: Insufficient Information

  MAUDE report 21091900 ↗
• MalfunctionDec 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT PHARMACY TECHNICIAN WAS COMPOUNDING A NIVOLUMAB 480 MG / 48 ML DOSE. AFTER PRIMING THE TUBING, IT WAS NOTED THE HOOD WAS WET UNDERNEATH THE TUBING AND THE TECHNICIAN REALIZED THAT THE TUBING WAS LEAKING AT THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032749 ↗
• MalfunctionDec 9, 2024Leak/Splash; Leak/Splash

  MATERIAL # (B)(4), BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING WHERE THE TEXIUM IS BONDED TO THE PUMP SET AND SET CAME APART AT THE CONNECTION TO THE DRIP CHAMBER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTED 2 ADDITIONAL QUALITY ISSUES EXPERIENCED WITH 24301-0007T: 1) LEAKING WHERE THE TEXIUM IS BONDED TO THE PUMP SET. EVENT OCCURRED ON (B)(6) 2024. LOT # IS UNKNOWN. SET WAS NOT SAVED. 2) SET CAME APART AT THE CONNECTION TO THE DRIP CHAMBER. EVENT OCCURRED ON (B)(6) 2024. LOT # IS UNKNOWN. SET WAS SAVED. PLEASE PROVIDE A SHIPPING LABEL TO XXX THAT IS COPIED ON THIS EMAIL. THE CUSTOMER CONTACT IS XXX PLEASE COPY ME, XXX AND XXX ON THE COMMUNICATION TO THE CUSTOMER THAT INCLUDES THE PR #¿S. CUSTOMER RESPONSE ON (B)(6) 2024. 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 2. COULD YOU PLEASE CONFIRM IF THE LEAK OCCURRED WHEN THE SET CAME APART AT THE CONNECTION TO THE DRIP CHAMBER? YES. 3. COULD YOU PLEASE CONFIRM WHAT MEDICATION WAS BEING ADMINISTERED AND LEAKED. WAS THIS A CHEMOTHERAPY DRUG? YES, THIS WAS A CHEMOTHERAPY DRUG.

  Patient problems: Chemical Exposure

  MAUDE report 20879388 ↗
• MalfunctionDec 9, 2024Material Separation; Material Separation

  MATERIAL#: 24301-0007T, BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING WHERE THE TEXIUM IS BONDED TO THE PUMP SET AND SET CAME APART AT THE CONNECTION TO THE DRIP CHAMBER. RCC RECEIVED A COMPLAINT VIA EMAIL. XXXX REPORTED 2 ADDITIONAL QUALITY ISSUES EXPERIENCED WITH 24301-0007T: 1) LEAKING WHERE THE TEXIUM IS BONDED TO THE PUMP SET. EVENT OCCURRED ON 11/21/2024. LOT# IS UNKNOWN. SET WAS NOT SAVED. 2) SET CAME APART AT THE CONNECTION TO THE DRIP CHAMBER. EVENT OCCURRED ON 11/21/2024. LOT#: IS UNKNOWN. SET WAS SAVED. PLEASE PROVIDE A SHIPPING LABEL TO XXX THAT IS COPIED ON THIS EMAIL. THE CUSTOMER CONTACT IS XXX PLEASE COPY ME, XXX AND XXX ON THE COMMUNICATION TO THE CUSTOMER THAT INCLUDES THE PR #¿S. CUSTOMER RESPONSE ON (B)(6) 2024. 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. 2. COULD YOU PLEASE CONFIRM IF THE LEAK OCCURRED WHEN THE SET CAME APART AT THE CONNECTION TO THE DRIP CHAMBER? YES. 3. COULD YOU PLEASE CONFIRM WHAT MEDICATION WAS BEING ADMINISTERED AND LEAKED. WAS THIS A CHEMOTHERAPY DRUG? YES, THIS WAS A CHEMOTHERAPY DRUG.

  Patient problems: Chemical Exposure

  MAUDE report 20879358 ↗
• MalfunctionDec 8, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 24301-0007T, BATCH NUMBER#: 24085241. IT WAS REPORTED BY CUSTOMER THAT COMPOUNDING A NIVOLUMAB 480 MG / 48 ML DOSE. AFTER PRIMING THE TUBING, THEY NOTICED HOOD WAS WET UNDERNEATH THE TUBING AND REALIZED THAT THE TUBING WAS LEAKING AT THE FILTER. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I WAS COMPOUNDING A NIVOLUMAB 480 MG / 48 ML DOSE. AFTER PRIMING THE TUBING, I NOTICED MY HOOD WAS WET UNDERNEATH THE TUBING AND REALIZED THAT THE TUBING WAS LEAKING AT THE FILTER. ITEM# 24301-0007T, LOT# (10)24085241.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20874941 ↗
• MalfunctionDec 8, 2024Leak/Splash; Leak/Splash

  MATERIAL # 24301-0007T. BATCH # 24085241. IT WAS REPORTED BY CUSTOMER THAT LEAKING FROM THE BONDED AREA BETWEEN THE END OF THE TUBING AND THE TEXIUM. VERBATIM: LOT# 24085241-24301-0007T- REPORTED LEAKING FROM THE BONDED AREA BETWEEN THE END OF THE TUBING AND THE TEXIUM. CHEMO EXPOSURE TO PATIENT AND PREGNANT CLINICIAN.

  Patient problems: Chemical Exposure

  MAUDE report 20874940 ↗
• MalfunctionDec 6, 2024Leak/Splash; Leak/Splash

  MATERIAL: 24301-0007T; BATCH#: 24085241. IT WAS REPORTED BY THE CUSTOMER THAT TUBING LEAKING FROM FILTER UPON PRIMING TUBING. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867199 ↗
• MalfunctionDec 6, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20866684 ↗
• MalfunctionDec 6, 2024Material Separation; Material Separation

  MATERIALS: 24010-0007T BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THERE HAVE BEEN SEVERAL EVENTS INVOLVING BD TEXIUM TUBING AND SYRINGES WHERE NURSES AND PATIENTS HAVE BEEN AT RISK FOR EXPOSURE TO HAZARDOUS DRUG DUE TO LEAKING PRODUCTS. CHAMBER BROKE OFF OF THE IV TUBING AND CHEMOTHERAPY WAS RAPIDLY SPILLING OUT OF THE IV BAG.

  Patient problems: Insufficient Information

  MAUDE report 20864519 ↗
• MalfunctionDec 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THERE WAS LEAKAGE FROM THE TEXIUM MALE LUER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20850028 ↗