Alaris, SmartSite, Texium 22602-B007TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403240935), received between Sep 1, 2023 and Dec 13, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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. 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. 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 ↗

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 ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 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 CONNECTION BETWEEN THE TWO PRODUCTS BEGAN LEAKING APPROXIMATELY 15 MINUTES INTO THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23798700 ↗
• MalfunctionDec 3, 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: IT WAS REPORTED BY CUSTOMER THAT THEY HAD ANOTHER LEAKING LINE TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705735 ↗
• MalfunctionDec 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD 4 INSTANCES OF ANTINEOPLASTIC LEAKING FROM THE CONNECTION POINT BETWEEN THE MALE LUER COMPONENT ON THE TEXIUM LINE (THE GREEN LUER LOCK END) TO THE DISTAL FEMALE ACCESS PORT ON THE PRIMARY BD IV TUBING. THE LOT NUMBER AND EXPIRATION DATE OF THE TEXIUM LINE INVOLVED WITH THE MOST RECENT LEAK (TODAY) IS: LOT# 25045002, EXP: 03/31/2028. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO, HAZARDOUS SPILL WAS CLEANED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677531 ↗
• MalfunctionNov 21, 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 CONNECTION BETWEEN THE TWO PRODUCTS BEGAN LEAKING APPROXIMATELY 15 MINUTES INTO THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619738 ↗
• MalfunctionNov 21, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619734 ↗
• MalfunctionOct 22, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364249 ↗
• MalfunctionSep 25, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD AS LVP SS BAG 20D LOW SORB TEX LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT LEAKING. RESPONSE RECEIVED ON 18-SEP-2023: 1. PLEASE DESCRIBE HOW WAS THE ISSUE WAS FIRST DISCOVERED? LEAK HAPPENED ABOUT 1 HR AFTER THE TACRO BAG WAS CHANGED. 2. ARE YOU ABLE TO IDENTIFY THE LOCATION OF LEAKING? 3. WAS THERE ANY DAMAGE ON THE PRODUCT THAT MAY HAVE CAUSED THE LEAKAGE? NO. 4. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? 5. WHAT SOLUTION/MEDICATION WAS USED DURING THE INCIDENT? TACROLIMUS. 6. WAS THERE ANY PATIENT INVOLVEMENT? IF YES, WHAT WAS THE PATIENT OUTCOME? NO HARM TO PATIENT. 7. PLEASE CONFIRM IF THERE WAS ANY ADVERSE EVENT OR SERIOUS INJURY? NONE. 8. PLEASE CONFIRM THE QUANTITY OF DEFECTIVE PRODUCT INSPECTED. ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814661 ↗
• MalfunctionSep 1, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM  LOW SORBING INFUSION SET HAS A SMALL HOLE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS AFTERNOON ONE OF OUR TUBING SETS HAD A SMALL HOLE IN IT IN THE AREA RIGHT BEFORE IT IS INSERTED INTO THE PUMP. IT RESULTED IN A CHEMOTHERAPY SPILL AND APPROXIMATELY 10 ML OF DRUG LOSS. WE HAVE NOT HAD ISSUES WITH THIS PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671583 ↗