Alaris, SmartSite, Texium 24010-0007TRecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve 3 Y-Sites, 321 cm (126 in) · Class 2
All models of Alaris, SmartSite, Texium (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Alaris SmartSite Texium infusion set is tubing used to pump drugs, including chemotherapy, into a patient. Most of the 53 reports describe the set leaking or dripping at the connection above the green cap or where the tubing is bonded, sometimes letting drug spill out; one injury was reported and no deaths. Three recalls are open, including one that started in May 2025 over leaking at the closed male luer connection and another in August 2026 over performance data differences that may lead to inappropriate pump performance.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10885403271021), received between May 15, 2019 and Sep 25, 2026 — classified as 1 injury, 53 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (38 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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 ↗
- 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 ↗
Most reported problems
Device problems
- Leak/Splash38
- Fluid/Blood Leak8
- Material Separation6
- Backflow2
- Defective Device2
- Complete Blockage1
- Device Fell1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Information7
- No Consequences Or Impact To Patient3
- Fluid Discharge2
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Loose or Intermittent Connection
Patient problems: Insufficient Information
MAUDE report 50903523 ↗MalfunctionMar 17, 2026Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT CHEMO TUBING WAS LEAKING ABOVE GREEN CAP. PRE HYDRATION ONLY, NO CHEMO SPILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618184 ↗MalfunctionFeb 27, 2026
PATIENT NOTICED WET FEELING ON SKIN. UPON RN'S INVESTIGATION, CHEMO TUBING WAS LEAKING ABOVE GREEN CAP. PRE-HYDRATION ONLY, NO CHEMO SPILL. TEXIUM IS BONDED ONTO TUBING. LEAKING WAS NOTED WHERE THE TEXIUM IS BONDED ONTO THE STRAIGHT SET. THIS WAS A ONE TIME ISSUE. HAVE NOT HEARD OF OTHER ISSUES FROM THIS LOT OR RELATED TO BONDED TEXIUM.
Patient problems: Insufficient Information
MAUDE report 24469234 ↗MalfunctionDec 16, 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 A CUSTOMER THAT THE SLOW STREAM OF CHEMOTHERAPY DRUG WAS OBSERVED LEAKING FROM THE ACCESS PORT WHEN CONNECTED TO A BAG OF FLUID (SALINE SOLUTION OR D5W) PRIMARY LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824506 ↗MalfunctionDec 12, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794936 ↗MalfunctionDec 12, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794927 ↗MalfunctionOct 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: IT WAS REPORTED BY CUSTOMER THAT BD ALARIS PUMP INFUSION SET WITH BONDED TEXIUM LEAKED DURING INFUSION. RESULTED IN POLATUZUMAB DRUG SPILL ON AN INVESTIGATIONAL PATIENT. LEAKS WITH BD BONDED AND UN-BONDED TEXIUM PRODUCTS HAVE BEEN OCCURRING AT THIS SITE OVER THE PAST 9 MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350261 ↗MalfunctionOct 19, 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 THEY NOTICED THERE WERE 5-6 DROPS ON THE FLOOR AND THERE WAS LEAKAGE AROUND THE TEXIUM THAT WAS CONNECTED TO THE PRIMARY TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333718 ↗MalfunctionAug 11, 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 22779935 ↗MalfunctionJul 22, 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 MULTIPLE LINES OF TUBING FROM THE SAME LOT NUMBER START LEAKING DURING THE INFUSION. THE LOT NUMBER IS (10)25045192. IT SEEMS TO BE LEAKING FROM THE TEXIUM GREEN CAP AT THE END. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: 1. COULD YOU PLEASE PROVIDE EXACT NUMBER OF OCCURRENCES? 5 2. PLEASE LET US KNOW THE MEDICATION BEING ADMINISTERED AND LEAKED? WAS IT A CHEMOTHERAPY DRUG? IVF AT BOLUS RATE AND PREMEDS (DEX AND PEPCID) 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT WAS HARMED OR INJURY. ONLY TIME AND PRODUCT REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22571707 ↗MalfunctionJul 8, 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 "CONNECTION LEAKING ON IV TUBING SET."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435376 ↗MalfunctionMar 21, 2025Leak/Splash; Leak/Splash
IMDRF CODES MUST BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21666068 ↗MalfunctionMar 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM 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 IV PIGGYBACK CYTARABINE CHEMO APPEARED TO BE LEAKING AT THE Y-SITE ABOVE THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620909 ↗MalfunctionMar 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED: ¿PATIENT RECEIVING DAUNORUBICIN IV PUSH THROUGH TEXIUM TUBING. AT SITE WHERE PRE-PACKAGED PRIMARY TUBING CONNECTED TO TEXIUM SMALL AMOUNT OF LEAKING OF DRUG OBSERVED. MORE LEAKING AT THIS SITE OCCURRED AFTER REMOVING DAUNORUBICIN SYRINGE FROM Y SITE OF TUBING. LOT NUMBER (10)24075225, REF 24010-0007T.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21590557 ↗MalfunctionMar 11, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21580092 ↗MalfunctionMar 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE LEAK OCCURRED WITH NURSING PRIMARY TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21511486 ↗MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT IT WAS VERY HIGH AND URGENT. LIKELY LEAKING AT BONDED TEXIUM SITE ON THE ABOVE TUBING WHICH NURSING USES ¿ SOMETIMES IT¿S HARD TO TELL AS THE LEAKING CAN OCCUR WHERE THE TEXIUM BONDED ADAPTOR CONNECTS TO THE CLAVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21401844 ↗MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM CHEMO TUBING LEAKED WHILE MEDICATION WAS BEING FLUSHED THROUGH LINE AFTER 5FU PUSH. CHEMO TUBING LEAKED AT THE END OF THE TUBING WHERE TEXIUM CLAVE IS FUSED. CHEMO TUBING WAS PUT INTO CHEMO BAG AND RETURNED TO PHARMACY ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21394091 ↗MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21351778 ↗MalfunctionJan 13, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM . IT WAS REPORTED BY CUSTOMER THAT LEAKING ALARIS SETS WHEN NURSES ARE GIVING AN IV PUSH OF CHEMOTHERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21141651 ↗MalfunctionDec 6, 2024Leak/Splash; Leak/Splash
MATERIAL # 24010-0007T. BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT PATIENT WAS RECEIVING ADRIAMYCIN VIA IVP. WHEN PUSHING THE LAST 1-2 ML OF THE MEDICATION, THERE WAS LEAKAGE BETWEEN THE TUBING AND THE TEXIUM CAP SITE THAT SHOULD BE GLUED/CONNECTED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864496 ↗MalfunctionDec 6, 2024Defective Device; Defective Device
MATERIAL # 24010-0007T. BATCH # 24055598. IT WAS REPORTED BY CUSTOMER THAT TEXIUM TUBING USED TO PRIME CHEMO FLUSH BAG WAS NOT FUNCTIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864337 ↗MalfunctionDec 6, 2024Defective Device; Defective Device
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864081 ↗MalfunctionDec 6, 2024Leak/Splash; Leak/Splash
MATERIAL # 24010-0007T; BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT PATIENT WAS RECEIVING ADRIAMYCIN VIA IVP. WHEN PUSHING THE LAST 1-2 ML OF THE MEDICATION, THERE WAS LEAKAGE BETWEEN THE TUBING AND THE TEXIUM CAP SITE THAT SHOULD BE GLUED/CONNECTED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864072 ↗MalfunctionDec 6, 2024Leak/Splash; Leak/Splash
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. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 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. WE HAVE BEEN IN CONTACT WITH BD BUT HAVE NOT YET FOUND A RESOLUTION TO THIS ISSUE. MODEL #: 24010-0007T. (B)(6) 2024 (B)(6) - 24010-0007T LOT / EXP NOT AVAILABLE - DURING DOXORUBICIN. INFUSION, THE Y-SITE WHERE THE SYRINGE IS CONNECTED TO THE PRIMARY TUBING WAS LEAKING WHEN THE MEDICATION WAS ADMINISTERED. 2 OUT OF 3 SYRINGES LEAKED AT THE Y-SITE. MAY INVOLVE MY8020/MY8030 SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864000 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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