Alaris, SmartSite C24105ERecalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 5 Y-Sites, 281 cm (111 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613203019040), received between Jan 24, 2019 and Jan 24, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “No Audible Alarm” (1 report).
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
- No Audible Alarm1
Patient problems
- Respiratory Distress1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 24, 2019No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THAT THE DEVICE ALLOWED AIR BUBBLES THROUGH THE AIR-IN-LINE DETECTOR WITHOUT ALARMING DURING A D5%NS INFUSION AT 150ML/HR, AND A SECONDARY ZOFRAN 16MG INFUSION OVER 15 MINUTES. THE AIR-IN-LINE DETECTION WAS SET TO 75 MICROLITERS AND THE ACCUMULATED AIR SETTINGS WERE ENABLED. ALTHOUGH THERE WAS NO LASTING INJURY, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND THE NURSE PRACTITIONER WAS NOTIFIED. THE DEVICE WAS SEQUESTERED WITH THE IV ADMINISTRATION SET DISCONNECTED. THE BIOMED DEPARTMENT TESTED THE DEVICE ON 12/21/2018 AND FOUND NO DISCREPANCIES USING THE CALIBRATED ADMINISTRATION SET AND A CALIBRATED DRYSET (ASM CHECK-IN TEST). THEY ALSO PERFORMED AN AIR BUBBLE DETECTION TEST AND NO AIR WAS NOTED IN THE LINE. THE CUSTOMER WOULD LIKE SECOND OPINION REGARDING THE ADMINISTRATION SET THAT WAS USED ON THE PATIENT BECAUSE THERE WERE 2 LINES CONNECTED TO IT, AS WELL AS THE LVP UNIT.
Patient problems: Respiratory Distress
MAUDE report 8274213 ↗
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