Alaris, SmartSite, Texium 22000-B007TRecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Bag Access non Vented Low Sorbing Tubing (PE line) Bonded close Male Luer with priming cap 115 cm (45 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.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403245022), received between Nov 21, 2018 and Sep 2, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 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/Splash6
- Fluid/Blood Leak4
- Disconnection2
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 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 LEAKED FLUID WAS LEAUCOVORIN. THIS HAPPENED DURING ADMINISTRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929862 ↗MalfunctionAug 15, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKED AT THE MALE LUER, CHEMO WAS BEING ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 22822561 ↗MalfunctionJul 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE TEXIUM INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKED AT THE MALE LUER, CHEMO WAS BEING ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 22577625 ↗MalfunctionMar 28, 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 FROM TEXIUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21727223 ↗MalfunctionOct 21, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AT LEAST ONE BD ALARIS¿ INFUSION PUMP EXPERIENCED DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE ADMINISTRATION OF THE MEDICATION, THE TUBING IS COLLAPSE AND SO IT PREVENT ADMINISTRATING THE REST OF THE MEDICATION TO THE PATIENT. IT HAPPENED SEVERAL TIME, TODAY IS ONE OF THE DAY THAT HAPPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12677381 ↗MalfunctionFeb 2, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AS LVP SS BAG 20D TEX LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 22000-B007T. BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THE TUBING WAS LEAKING FROM THE SECTION THAT SITS IN THE PUMP. VERBATIM: "I FOLLOWED UP WITH THE CHARGE NURSE FOR THE LEAKY GEMCITABINE FROM MONDAY. IT WAS A TUBING LEAK FROM THE SECTION THAT SITS IN THE PUMP."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11269066 ↗MalfunctionMay 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CHEMOTHERAPY MEDICATION, GEMZAR, LEAKED FROM THE TEXIUM TUBING WHILE CONNECTED TO A PATIENT. ALTHOUGH REQUESTED, THERE WERE NO FURTHER DETAILS OR INFORMATION PROVIDED AND NO REPORT OF HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8601444 ↗MalfunctionApr 4, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT USER NOTICED A CHEMO LEAK AT THE TEXIUM TUBING AND PRIMARY LINE WITHIN 1 HR. OF THE INFUSION. THE TEXIUM TUBING ON THE MALE LUER WOULD NOT ATTACHED TO THE PRIMARY LINE DUE TO THE "SPIN COLLAR WAS STRIPPED". THERE WAS NO PATIENT OR USER HARM .THE EVENT OCCURRED IN THE INPATIENT CHEMO UNIT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8483021 ↗MalfunctionApr 4, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT USER NOTICED A CHEMO LEAK AT THE TEXIUM TUBING AND PRIMARY LINE WITHIN 1 HOUR. OF THE INFUSION. THE TEXIUM TUBING ON THE MALE LUER WOULD NOT ATTACHED TO THE PRIMARY LINE DUE TO THE "SPIN COLLAR WAS STRIPPED". THERE WAS NO PATIENT OR USER HARM .THE EVENT OCCURRED IN THE OUT PATIENT CHEMO UNIT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8482974 ↗MalfunctionNov 21, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT A CHEMOTHERAPEUTIC MEDICATION COMPLETED AS A SECONDARY INFUSION WITH A TEXIUM ATTACHED TO THE PRIMARY NORMAL SALINE LINE. THE TEXIUM WAS CONNECTED/TIGHTENED CORRECTLY BUT DRIPPED WHEN THE NORMAL SALINE WAS FLUSHING THE LINE, EVEN WITH ADJUSTMENTS AND CHECKING THE LINE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8094809 ↗
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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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