Alaris, SmartSite 10404198Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 3 Y-Sites 389 cm (153 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403232527), received between Mar 27, 2018 and Mar 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment Of Device Component1
- Failure to Deliver1
- Failure to Prime1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2018Break; Detachment Of Device Component; Failure to Prime; Failure to Deliver
COLLECTIVELY OVER THE PAST WEEK OR SO WE'VE HAD 10 INFUSION SETS AT ISSUE (SEE DESCRIPTIONS BELOW). THERE WAS NO PATIENT HARM SO THERE IS NO PATIENT INFORMATION IN THIS REPORT. ALL BUT ITEM 1 WERE ISSUES WITH NON-PRIMING CAPABILITIES; 3 OF WHICH WERE FROM EMERGENCY ROOM AND SIX WERE FROM PEDIATRICS/L&D. SINCE THE REFERENCE NUMBERS AND ID NUMBERS WERE IDENTICAL ON THE SAVED DEVICES THE CONSENSUS WAS TO GET THE FDA NOTIFIED OF THE TREND. 1. PUMP TUBING BROKE WHILE IN EMERGENCY PATIENT WAS IN CT. THE BLUE PIECE SNAPPED RIGHT AT THE END OF THE INFUSION. THE TUBING WAS NOT BEING PULLED ON IN ANY WAY; WE WERE IN THE CONTROL ROOM AND THE PUMP SAID INFUSION COMPLETE AND THEN SECONDS LATER THE TUBING SNAPPED LOOSE FROM THE TOP OF PUMP AND SHOT UP IN AIR AND DUMPED THE LAST LITTLE BIT OF ABX ONTO THE BED. 2, 3, & 4. MANY PUMP TUBINGS IN THE EMERGENCY ROOM HAVE PROBLEMS WITH INITIAL PRIMING OF LINE. FREE FLOW DOES NOT OCCUR UNTIL SOME PRESSURE IS APPLIED TO CAUSE THE BACKFLOW VALVE TO "POP" OPEN INTERNALLY. 5 & 6 FROM L&D AND 7-10 PEDIATRICS WITH THE SIMILAR ISSUE: IV TUBING WOULD NOT PRIME AND PUMP WAS UNABLE TO INFUSE IV FLUIDS. PUMP TUBING CHANGED 3 TIMES AND PUMP CHANNEL CHANGED TWICE.N
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7373269 ↗
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