Alaris, SmartSite 2420-0007Recalls & 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
Quick summary
This BD Alaris SmartSite infusion set has 2,524 adverse event reports, including 4 deaths and 43 injuries. Many reports describe fluid leaks, material separating or breaking, and backflow, and many note no impact on the patient. One recall is closed, starting in May 2019, because tubing wall thickness can vary, so the tubing may not fully close and medication may flow when the pump is off 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
- 2,509
- Deaths reported
- 4
- Injuries reported
- 44
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2,509 adverse event reports that list this exact device (DI 07613203021012), received between Nov 7, 2017 and Sep 30, 2026 — classified as 4 deaths, 44 injuries, 2,461 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (653 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/Splash653
- Material Separation495
- Fluid/Blood Leak349
- Break192
- Backflow135
- Material Deformation106
- Infusion or Flow Problem93
- Defective Component84
Patient problems
- No Clinical Signs, Symptoms or Conditions1,358
- No Consequences Or Impact To Patient703
- No Patient Involvement200
- No Information175
- Insufficient Information49
- No Known Impact Or Consequence To Patient49
- Chemical Exposure9
- Low Blood Pressure/ Hypotension7
Recent adverse event reports
The 25 most recent of 2,509 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950577 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949386 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937958 ↗MalfunctionSep 29, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936977 ↗InjurySep 25, 2026Excess Flow or Over-Infusion
It was reported that the BD Alaris Pump Module SmartSite Infusion Set had flow issues.The following information was provided by the initial reporter: The alleged patient incident was pump over infused. Please see the incident details provided from Clinical staff in the NICU department below: NICU managers reported that NICU patient received excess dose of Glucose. Timeframe of Incident: (b)(6) 2026, 6pm (b)(6) 2026, 8am IV Bag start Volume: 200mL IV Bag end Volume: 76mL Alaris Pump Flow Rate: 4.2mL/hr. The manager also reported that they discarded the infusion tubing set that was attached to Alaris pumps at the time of incident. Serial number of units involved: PCU SN (b)(6) LVP SN (b)(6).Was there patient harm or injury? Yes (High Glucose).If so, kindly provide the details of what happened (patient symptoms and/or abnormal lab results). Chemstrip 600, serum glucose 668.What was the additional medical intervention provided to the patient? D12.5 TPN stopped and D5W starter TPN hung.What was the patient's outcome? Glucose came down and stabilized.What was the name of the medication/fluid that over infused? Glucose.What was the intended Volume to be Infused (VTBI)? 4.2ml/hr.What was t
Patient problems: Hyperglycemia
MAUDE report 50899357 ↗MalfunctionSep 24, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890867 ↗MalfunctionSep 24, 2026Material Separation
Patient problems: Atrial Fibrillation
MAUDE report 50889801 ↗MalfunctionSep 24, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889797 ↗MalfunctionSep 24, 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.It was reported by customer that Secondary line was rapidly backflowing into primary line despite proper gravity positioning. This was caught very quickly at the beginning of the infusion as it appeared to be runner much more quickly than the pump was programmed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876669 ↗MalfunctionSep 23, 2026Leak/Splash; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873028 ↗MalfunctionSep 21, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847333 ↗MalfunctionSep 21, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846925 ↗MalfunctionSep 21, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846903 ↗MalfunctionSep 21, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846898 ↗MalfunctionSep 21, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834926 ↗MalfunctionSep 20, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834906 ↗MalfunctionSep 18, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831233 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830709 ↗MalfunctionSep 18, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827359 ↗MalfunctionSep 17, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812127 ↗MalfunctionSep 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812125 ↗MalfunctionSep 17, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810384 ↗MalfunctionSep 17, 2026Material Separation
It was reported that BD alaris smartsite pump infusion set was separated The following information was received by the initial reporter with the following VerbatimIt was reported by the customer that we have had another issue with the BD Alaris IV tubing this morning. A primary line was primed with NS and, before it could be used, the tubing became completely detached just under the drip chamber.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797235 ↗MalfunctionSep 17, 2026Leak/Splash
It was reported that BD alaris smartsite pump infusion set was leaking.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that they had some tubing leak today.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797234 ↗MalfunctionSep 17, 2026Material Separation
It was reported that BD alaris smartsite pump infusion set was separatedThe following information was received by the initial reporter with the following VerbatimIt was reported by the customer that we have had another issue with the BD Alaris IV tubing this morning. A primary line was primed with NS and, before it could be used, the tubing became completely detached just under the drip chamber.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797233 ↗
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 · 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.
How reports and recalls are matched · Editorial policy · Report an error on this page