Alaris, SmartSite 10561554Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 Y-Sites 321 cm (126 in) · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403232565), received between Sep 15, 2023 and Dec 9, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (2 reports).
2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 19, 2026Open, Classified
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Z-3080-2026 · Root cause: Device Design · FDA record ↗
- Jul 8, 2025Open, 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-2180-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Complete Blockage2
- Expiration Date Error1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Material Separation; Material Separation
MATERIAL: 10561554 BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT TUBING BROKE OFF AT THE END OF THE INFUSION WHILE IT WAS FLUSHING. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20877854 ↗MalfunctionOct 11, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428368 ↗MalfunctionOct 11, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM PRODUCTCOMPLAINT - CUSTOMER CALLED TO REPORT THAT THEY HAVE EXPERIENCED ISSUES WITH THE BD INFUSION SET - REF 10561554 LOT 23125111, CUSTOMER STATED THAT TUBING COLLAPSES DURING INFUSION ON A PT CAUSING OCCLUSION, THIS ISSUE HAS OCCURRED WITH THIS PT A COUPLE OF TIMES AND ALSO ON ANOTHER PT. THERE IS NO INJURY OR PT HARM. JUST THAT THE PT DOES NOT GET FULL DOSE OF THE MEDICATION BEING INFUSED. SAMPLES AVAILABLE - DATE OF EVENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428191 ↗MalfunctionSep 15, 2023Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: A TUBING SET (REF10561554) WAS USED ON (B)(6) 2023, AFTER ITS EXPIRATION DATE OF 17AUG2023. I WANTED TO REACH OUT TO SEE IF THERE WAS ANY PERTINENT INFORMATION THAT I NEEDED TO KNOW PRIOR TO REPORTING THIS ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17756116 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.