Alaris, SmartSite 2421-0500Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve, 2 Y-Sites 297 cm (117 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613203019149), received between Jul 10, 2019 and Nov 7, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).
1 FDA recall record name this device's identifier.
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
- May 6, 2019Class ITerminated
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
Z-1770-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper Flow or Infusion1
- Insufficient Device Problem Information1
Patient problems
- Apnea1
- Cardiopulmonary Arrest1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "INFANT WENT APNEIC. NO RESPONSE TO STIMULATION. INTUBATED. SEE CODE SHEET FOR TIMES AND MEDICATIONS GIVEN PER DR. PER CODE EMERGENCY DRUG SHEET AT BEDSIDE.." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. ALTHOUGH MULTIPLE ATTEMPTS MADE FOR EVENT DETAILS THERE WAS NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER OR PATIENT IMPACT. AT THIS TIME .
Patient problems: Apnea; Cardiopulmonary Arrest
MAUDE report 9290577 ↗MalfunctionJul 10, 2019Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHEN HANGING ALBUMIN OR THICKER MEDICATION THE USER EXPERIENCED VENTING ISSUES. THE CUSTOMER REQUESTING AN ADAPTER TO FACILITATE FLOW. THE RN LATER REPORTED THAT THERE WAS MULTIPLE DIFFERENT TYPES OF TUBING SETS, BOTH GRAVITY AND PUMP SETS, WHEN INFUSING THICKER FLUIDS SUCH AS ALBUMIN EXPERIENCED VENTING ISSUES. THE CUSTOMER TYPICALLY USES THE LARGEST LUMEN OF THE CENTRAL LINE. WHILE THE VENT IS OPEN WHEN PRIMED THERE WAS NO PATIENT HARM
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8776737 ↗
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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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