Alaris, SmartSite 10013034Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 Y-Sites 325 cm (128 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403232312), received between Jun 17, 2020 and Nov 10, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (2 reports).
1 FDA recall record name this device's identifier, 1 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.
Recalls naming this device
- Sep 11, 2025Class IOpen, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Z-0035-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Free or Unrestricted Flow2
- Packaging Problem1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET PACKAGING HAD A HOLE IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HOLE IN BD PACKAGING"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12790843 ↗MalfunctionJun 22, 2020Free or Unrestricted Flow; Free or Unrestricted Flow
IT WAS REPORTED THAT AS LVP 20D DEHP 3SS 2G-4WSPK CV HAD AIR IN THE LINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10013034 BATCH NO.: UNKNOWN IT WAS REPORTED THERE WAS AIR IN THE TUBING. I AM THE CLINICIAN THAT WORKS WITH THE ALARIS PUMP TUBING. I JUST LEFT A VOICEMAIL AND WANTED TO FOLLOW UP WITH AN EMAIL AS WELL. I AM SORRY THAT YOUR FACILITY IS EXPERIENCING SO MANY AIR IN LINE ISSUES WITH OUR TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10179702 ↗MalfunctionJun 17, 2020Free or Unrestricted Flow; Free or Unrestricted Flow
IT WAS REPORTED THAT AS LVP 20D DEHP 3SS 2G-4WSPK CV HAD AIR IN THE LINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING LOTS OF TROUBLE AGAIN WITH OUR STOPCOCK TUBING THAT IS USED ON LABOR AND DELIVERY. SAME ISSUES AS BEFORE IT IS ALWAYS THE AIR ALARM WHEN INITIATING THE IV AND WE TRY DIFF PUMPS, DIFFERENT TUBINGS (WASTING MANY) AND STILL CAN'T GET THE IV PUMP TO WORK. IF WE CHANGE IT OUT TO A PRIMARY TUBING IT WORKS EVERY TIME. WE ARE THROWING MONEY AWAY DAILY AND FRUSTRATING MANY STAFF DUE TO THIS ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10163569 ↗
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- 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 · 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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