Alaris, SmartSite, Texium 70003BE-07TRecalls & reported problems
BD Switzerland Sàrl · 45in Sec Set 20DP SS bag ac DEPH free LS · Class 2
All models of Alaris, SmartSite, Texium (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403278358), received between Jul 31, 2019 and Jul 31, 2019 — classified as 2 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
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING A CHEMOTHERAPY INFUSION OF CISPLATIN 110MG/500 ML MANNITOL/ NS AT 500ML/HR OVER 1 HOUR, THE SET SEPARATED FROM THE CISPLATIN BAG AND LEAKED. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8845916 ↗MalfunctionJul 31, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CHEMO MEDICATION DARATUMUMAB LEAKED FROM AN UNIDENTIFIED LOCATION ON THE TUBING DURING AN INFUSION TO A PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8845913 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page