Alaris, SmartSite 2426-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve 3 Y-Sites, 320 cm (126 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Alaris SmartSite infusion set from BD has 1,409 FDA adverse event reports, with 19 injuries, 1,385 malfunctions and 5 deaths. The reports mostly describe fluid leaking, material separating or breaking, and air or gas getting into the set. One closed recall names this device; it began in May 2019 over infusion tubing with uneven walls that can let medication flow unintentionally or faster than expected.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,401
- Deaths reported
- 5
- Injuries reported
- 19
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,401 adverse event reports that list this exact device (DI 10885403227998), received between Dec 12, 2017 and Sep 30, 2026 — classified as 5 deaths, 19 injuries, 1,377 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (403 reports).
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.
Reports received per month
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
- Leak/Splash403
- Material Separation201
- Fluid/Blood Leak145
- Break94
- Air/Gas in Device72
- Defective Component65
- Backflow58
- Complete Blockage52
Patient problems
- No Clinical Signs, Symptoms or Conditions938
- No Consequences Or Impact To Patient272
- No Information67
- Insufficient Information43
- No Known Impact Or Consequence To Patient43
- No Patient Involvement25
- Chemical Exposure6
- Low Blood Pressure/ Hypotension6
Recent adverse event reports
The 25 most recent of 1,401 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950937 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950933 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950928 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950927 ↗MalfunctionSep 30, 2026Break
It was reported that BD alaris smartsite pump infusion set was damaged.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that experiencing tubing that is ¿breaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949385 ↗MalfunctionSep 25, 2026Leak/Splash; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903520 ↗MalfunctionSep 22, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856443 ↗MalfunctionSep 21, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846912 ↗MalfunctionSep 21, 2026Leak/Splash; Material Separation
It was reported that the BD Alaris Pump Module SmartSite Infusion Set had separated.The following information was provided by the initial reporter: Tubing was primed and began leaking. Medication recovered and placed in new tubing. After looking at tubing further and assessing, tubing was coming apart and an insertion site near a port on the tubing. It came apart very easily and could have caused loss of medication or problems with IV or being exposed to air in line. Manufacturer and Number: BD Alaris pump /26056098Lot Number: 630-03361Patient harm: No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839415 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831244 ↗MalfunctionSep 18, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831242 ↗MalfunctionSep 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831241 ↗MalfunctionSep 18, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831232 ↗MalfunctionSep 18, 2026Stretched
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830712 ↗MalfunctionSep 18, 2026Leak/Splash; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829594 ↗MalfunctionSep 17, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809424 ↗MalfunctionSep 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808554 ↗MalfunctionSep 17, 2026Backflow
It was reported that BD alaris smartsite pump infusion set had flow issues.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that the fluid backing up into primary drip chamber from secondary infusion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808546 ↗MalfunctionSep 17, 2026Complete Blockage
It was reported that the BD Alaris Pump Module SmartSite Infusion Set was occluded.The following information was provided by the initial reporter: When running pitocin with the main line fluids, we have to turn the rate of the main line way down, or it will beep occlusion on the pt side of the pitocin line. We are having to turn our maintenance fluids down very low to get the pitocin to run.Has there been any patient harm? No instances of patient harm reported. It is the potential for patient harm that concerns the staff. Please give a detailed description of the event. For induction of labor, the oxytocin administration starts with 2 ml/hr and a maintenance fluid of 50 ml/hr. BD Alaris pumps begin to alarm for pressure, and the oxytocin will stop running (alarms ¿occluded on patient side.¿). The maintenance fluids must be decreased to 25 ml/hr to get oxytocin running again. IF the patient elects to have an epidural, the maintenance fluid needs to be increased to help prevent hypotension, but this can be a challenge if the oxytocin continues to alarm ¿occluded on patient side.¿ List all interventions provided to the patient. None. It is an equipment issue.Please list the serial num
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806111 ↗MalfunctionSep 14, 2026Fluid/Blood Leak; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764412 ↗MalfunctionSep 14, 2026Fluid/Blood Leak; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764378 ↗MalfunctionSep 14, 2026Fluid/Blood Leak; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764373 ↗MalfunctionSep 14, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763206 ↗MalfunctionSep 11, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744357 ↗MalfunctionSep 8, 2026Nonstandard Device; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678258 ↗
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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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