BD Alaris Pump Module model 8100

Class I Recall (Correction)

The FDA has issued an early alert to healthcare providers and patients regarding a performance issue affecting BD Alaris Pump Module model 8100, used with specific compatible infusion sets. BD, through its subsidiary CareFusion, has distributed an Urgent Medical Device Recall (Correction) letter outlining concerns about the accuracy of flow rate, bolus delivery, and alarm timing under certain conditions.

What’s the Issue?

The BD Alaris 8100 infusion pump may show worsened performance when used with a subset of compatible pump infusion sets—especially those containing a 0.2-micron in-line filter. The key concerns include:

• Inaccurate flow rates
• Delayed alarms
• Bolus volumes outside expected ranges

These issues could increase the risk of under- or over-infusion in critical care settings.

What Should Users Do?

BD has advised that devices may continue to be used, but specific precautions should be taken to reduce risks. If your facility uses the affected infusion sets, please:

• Refer to updated performance data available in the BD Alaris User Manuals.
• Follow all existing warnings and recommendations related to:
  • Flow rate and bolus accuracy
  • Time to alarm
  • Post-occlusion bolus volume (POBV)

For the 0.2-micron in-line filter infusion set specifically:

• Ensure tubing is not kinked, clamps are open, and drops are flowing in the drip chamber.
• Avoid infusion rates below 1 mL/h.
• Do not use pressure mode settings above 50 mmHg for rates under 10 mL/h.

Facility Action Items

• Post the BD Customer Notification near all affected devices.
• Share the notice with all staff responsible for infusion pump use.
• If issues are encountered, report them to BD at: productcomplaints@bd.com

Stay Updated

The FDA continues to evaluate this issue as potentially high-risk and will update the public with any new findings. For the most current information, visit the FDA’s Medical Device Recalls page.

If you need help identifying affected equipment or implementing corrective actions, don’t hesitate to reach out to your BD representative or internal clinical engineering team.

Early Alert: Infusion Set Performance Issue from BD

The FDA is aware that BD and their subsidiary CareFusion have issued an “Urgent Medical Device Recall (Correction)” letter notifying affected customers of worse performance, under certain use cases, for the BD Alaris Pump Module model 8100 (pump module) when used with a subset of compatible pump infusion sets.

What to Do

Refer to the updated set performance data as compared to the existing set performance data found in User Manuals. Follow applicable warnings and recommendations from the User Manual to mitigate risks associated with these infusion parameters. Consider using additional mitigations with the 0.2-micron in-line filter infusion set.

On July 8, BD sent all affected customers a letter recommending the following actions:

• Devices can continue to be used as intended.
• The User Manuals currently provide applicable warnings and recommendations for clinical users to mitigate the risks associated with conditions that shift flow rate accuracy, time to alarm, and bolus accuracy performance.
• Please refer to the recommendations and warnings from the BD Alaris User Manual regarding rate and bolus accuracy, time to alarm, and post-occlusion bolus volume (POBV).
• The following actions should be considered for the 0.2-micron in-line filter infusion set:
• Ensure all clamps are open; there are no kinks or collapses in the tubing outside of the pump; drops are flowing in the drip chamber.
• Avoid infusion flow rates below 1 mL/h.
• Avoid using Selectable pressure mode with a setting above 50 mmHg for rates less than 10 mL/h.
• Post this Customer Notification on or near the affected products. If you experience any issues, contact BD at productcomplaints@bd.com
• Circulate this notice within your facility network to ensure that all concerned personnel are made aware of this issue.

Check the FDA recall web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.