Alaris, SmartSite, Texium 22603-B007TRecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Bag Access, Non-Vented, Low Sorbing Tubing (PE Lined), Bonded Closed Male Luer with Priming Cap, 120 cm (47 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 pump infusion set is a tubing set with a bag access port used to pump IV medicines, including chemotherapy. The 54 reports mostly describe leaking or splashing at the connection points and ports, sometimes forcing staff to remake medication, along with occasional blockages that stopped or interrupted infusions. There are no deaths and no injuries reported. Three recalls are open, covering performance data discrepancies, leaking at the luer/needle-free connector junction, and labeling that said the sets were free of DEHP when they were not.
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
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10885403240942), received between Aug 21, 2018 and May 11, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (42 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 ↗
- 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 ↗
- 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
Device problems
- Leak/Splash42
- Fluid/Blood Leak6
- Contamination /Decontamination Problem4
- Complete Blockage3
- Connection Problem2
- Crack1
- Device Contamination with Chemical or Other Material1
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- No Consequences Or Impact To Patient3
- No Patient Involvement3
- Chemical Exposure1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER IS THAT 23.5 HOURS WAS ENTERED FOR THE DURATION BUT SHOULD HAVE ENTERED A DURATION OF 2330 HOURS. DURING THE INFUSION THERE WERE THREE PATIENT SIDE OCCLUSION ALERTS AND THREE RESTARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144524 ↗MalfunctionMay 11, 2026Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER IS THAT 23.5 HOURS WAS ENTERED FOR THE DURATION BUT SHOULD HAVE ENTERED A DURATION OF 2330 HOURS. DURING THE INFUSION THERE WERE THREE PATIENT SIDE OCCLUSION ALERTS AND THREE RESTARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144522 ↗MalfunctionMay 11, 2026Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER IS THAT 23.5 HOURS WAS ENTERED FOR THE DURATION BUT SHOULD HAVE ENTERED A DURATION OF 2330 HOURS. DURING THE INFUSION THERE WERE THREE PATIENT SIDE OCCLUSION ALERTS AND THREE RESTARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144521 ↗MalfunctionMay 8, 2026Leak/Splash
IT IS REPORTED, ALARIS SMARTSITE ARE LEAKING, CHEMO HAD TO REMAKE THE MEDICATION, DUE TO A LEAK. ADDITIONAL INFORMATION: NO SERIOUS INJURIES NOTED, BUT HAD TO REMAKE CHEMO ON 3 SEPARATE OCCASIONS DUE TO LEAK CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? I DON'T HAVE SPECIFIC DATES, BUT NOTIFICATION DATES WERE AROUND 14/004/2026 - 16/004/2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123073 ↗MalfunctionApr 22, 2026Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NON-HAZARDOUS CHEMOTHERAPY (TRASTUZUMAB) LEAKED AT JUNCTION OF TUBING AND CLOSED SYSTEM TRANSFER DEVICE (CSTD) ADAPTOR. INJURIES OR ADVERSE EVENT: NO. ITEM: 22603-B007T. QUANTITY AFFECTED: 1EA. SERIAL/LOT NUMBER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960232 ↗MalfunctionApr 21, 2026Leak/Splash; Material Split, Cut or Torn
IT IS REPORTED, LARGE SLIT IN THE RUBBER STOPPER OF THE PORT, TUBING WAS LEAKING AT MEDICATION INJECTION PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941775 ↗MalfunctionApr 20, 2026Fluid/Blood Leak; Leak/Splash
IT IS REPORTED, LEAK BEGAN AT THE LIGHT BLUE PORT THAT IS CONNECTED TO THE CHEMO BAG. THE MEDICATION WAS CARBOPLATIN. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927312 ↗MalfunctionApr 10, 2026Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED, ALARIS SMARTSITE, MEDICATION WAS DRIPPING FROM THE CHEMO CONNECTOR POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844377 ↗MalfunctionApr 9, 2026Leak/Splash
IT WAS REPORTED LEAKAGE PROBLEM AROUND THE TEXIUM, CAUSING A CHEMO SPILL. ADDITIONAL INFORMATION: THE LEAK WAS CAUGHT 12 MINUTES AFTER THE BAG HAD BEEN RUNNING, SO A LARGE PUDDLE OF CHEMOTHERAPY DRUG/SOLUTION WAS ON THE FLOOR IN THE PATIENT'S AREA. THIS REQUIRED NURSING TO USE 2 CHEMOTHERAPY SPILL KITS TO CLEAN UP, POTENTIALLY EXPOSING OTHERS IN THE AREA BEFORE THE LEAK WAS FOUND.
Patient problems: Chemical Exposure
MAUDE report 24831066 ↗MalfunctionApr 6, 2026Leak/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 VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT TRACED DOWN AND FOUND A CHEMO SPILL OF ESTIMATED 2-3ML DIRECTLY UNDER CONNECTOR SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792447 ↗MalfunctionApr 6, 2026Connection Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT TRACED DOWN AND FOUND A CHEMO SPILL OF ESTIMATED 2-3ML DIRECTLY UNDER CONNECTOR SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792446 ↗MalfunctionApr 1, 2026Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24757931 ↗MalfunctionJan 14, 2026Fluid/Blood Leak; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24073464 ↗MalfunctionJan 9, 2026Leak/Splash; Connection Problem
TAXOL MEDICATION WAS DRIPPING FROM ATTACHMENT SITE ON PRIMARY TUBING. REQUIRED TREATMENT WAS STOPPED IMMEDIATELY. PATIENT HAD TO BE REMOVED FROM THE AREA AND SPILL CLEANED. CUSTOMER RESPONSE ON 23-DEC-2025: TREATMENT FOR THIS PATIENT WAS NOT DRAMATICALLY AFFECTED, THE PATIENT DID NOT COMPLETE THE BAG OF CHEMO, BUT LESS THAN 10% OF THE DRUG WAS WASTED. YOU CAN SEE IN THE PICTURE THE TOTAL SPILL WAS <5ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24029077 ↗MalfunctionJan 2, 2026Leak/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 INFUSION LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23949774 ↗MalfunctionDec 4, 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: LEAKING CHEMO DURING ADMINISTRATION. IT LOOKS LIKE THE ALARIS TUBING BUSTED ABOVE THE PUMP SEGMENT AND WAS LEAKING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23713160 ↗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 THE CUSTOMER THAT LEAK OCCURRED BETWEEN THE TEXIUM CONNECTION AND THE SMART SITE ON THE SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333563 ↗MalfunctionOct 16, 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: TEXIUM LEAKAGE DURING CHEMO / HD ADMINISTRATION. NO ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310332 ↗MalfunctionSep 4, 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 TEXIUM CONNECTION POINT ON THE BD ALARIS PUMP INFUSION SET WITH LOW SORB TUBING WAS LEAKING DURING AN INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974483 ↗MalfunctionSep 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 VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY HAD 3 MORE LEAKING INCIDENTS WITH THE SAME TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22958536 ↗MalfunctionSep 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 VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TEXIUM LEAKING FROM SMARTSITE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956948 ↗MalfunctionSep 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 VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TEXIUM LEAKING FROM SMARTSITE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956936 ↗MalfunctionSep 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 VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TEXIUM LEAKING FROM SMARTSITE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956930 ↗MalfunctionAug 26, 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 HAZARDOUS DRUG LEAKING FROM TEXIUM AND SMARTSITE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22891988 ↗MalfunctionAug 25, 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 HAZARDOUS DRUG LEAKING FROM TEXIUM AND SMARTSITE CONNECTION POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22891909 ↗
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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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