Alaris, SmartSite, Texium 24009-0007TRecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve, 2 Y-Sites, 298 cm (117 in) · Class 2
All models of Alaris, SmartSite, Texium (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403273827), received between Oct 23, 2018 and Jul 31, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Infusion or Flow Problem1
- Material Deformation1
- Structural Problem1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2019Structural Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE TUBING SILICONE SEGMENT BALLOONED AT THE START OF THE INFUSION DECITABINE VIA THE PUMP WHILE CONNECTED TO A PATIENT IN THE ONCOLOGY DEPARTMENT. THE BUBBLE STARTED TO BECOME LARGER AS THE NURSES STARTED THE INFUSION THROUGH THE INFUSION PUMP. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8845624 ↗MalfunctionJul 24, 2019Material Deformation; Material Deformation
PRODUCT WAS RECEIVED UNEXPECTEDLY WITH AN UNKNOWN ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8822882 ↗MalfunctionOct 23, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TEXIUM LEAKED TWO TIMES FROM THE DISTAL END OF THE TEXIUM-CONNECTION SITE DURING AN INFUSION OF DOXORUBICIN. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7997039 ↗MalfunctionOct 23, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TEXIUM LEAKED TWO TIMES FROM THE DISTAL END OF THE TEXIUM-CONNECTION SITE DURING AN INFUSION OF DOXORUBICIN. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7997031 ↗
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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
- 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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