An updated communication from the FDA highlights significant concerns regarding BD Alaris Infusion Sets’ performance under particular use conditions. Clinical, quality, and regulatory professionals need to act swiftly to mitigate risks associated with these devices. With vulnerable populations such as neonates and critically ill patients at heightened risk, navigating the updates is crucial.
What changed in the BD Alaris recall?
The FDA has identified the recent voluntary recall and correction of BD Alaris Pump Modules (model 8100) as critical due to severe performance deviations across specific compatible infusion sets. The devices in question may impact flow rate accuracy, time to alarm, and post-occlusion bolus volume (POBV), presenting heightened risks under low flow rates or conditions involving in-line components such as 0.2-micron filters.
Who is affected and what are clinical risks?
These adverse outcomes are particularly significant for neonatal, pediatric, and other critically vulnerable cohorts. Medication inaccuracies, both under-infusion and over-infusion, can lead to drug toxicity, overdose, or subtherapeutic effects. Furthermore, delays in upstream and downstream occlusion alarms increase the potential for missed treatment opportunities. Although BD has reported no deaths or serious injuries thus far, the unpredictable nature of these outcomes makes enhanced clinical oversight imperative.
Performance Deviations
According to BD, deviations in flow rate accuracy include ranges outside those published in User Manuals (v12.3-12.5). The most notable discrepancies appear when using 0.2-micron filter infusion sets at rates below 1 mL/h. Upstream time to alarm shifts from ≤2h 22 min to ≤3h 44 min, while downstream time to alarm extends beyond 1h 57 min. Rate accuracy may drop to -12.5%, potentially jeopardizing patient outcomes.
What actions should healthcare providers take?
The FDA advises clinicians and healthcare facilities to prioritize alternate solutions and implement risk mitigation strategies:
- Evaluate inventory to identify affected sets and prioritize alternative BD Alaris pump sets or modules for neonatal, pediatric, or critical-care use.
- If alternatives are unavailable, utilize BD Alaris Syringe Modules or comparable syringe pumps with enhanced monitoring.
- In scenarios requiring retained pump infusion sets, employ caution and implement risk mitigation practices specified in BD’s user manual (v12.3). This includes ensuring proper line setup, vent configurations, and pressure sensor alignment.
Addressing Specific Risks
- Avoid placing solution containers lower than the pump module or higher than 21 inches.
- Ensure clamps, tubing, and pressure settings meet defined safety standards.
- Balance disconnection risks when relieving post-occlusion bolus pressure to prevent unintended bolus delivery.
Recap and implications for clinical teams
Healthcare providers must remain vigilant, review available alternatives, and implement enhanced monitoring throughout high-risk administrations. Engage BD clinical consultants for analytics support or alternate inventory provision. Acting on these recommendations ensures safer device use while the recall process evolves.
Disclaimer
The information provided here applies exclusively to the outlined BD Alaris Infusion Sets. It is intended for educational purposes relating to regulatory affairs and does not constitute legal or clinical advice.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/update-alert-infusion-set-performance-issue-bd