|
The U.S. Food and Drug Administration is updating the communication “Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets” to notify the public that BD and its subsidiary CareFusion have issued an updated letter notifying affected customers of worse performance, under certain use cases, for the BD Alaris Pump Module model 8100. Due to the difficulty in recognizing these performance issues, users may fail to identify them as the cause of clinically significant changes in a patient’s condition. The letter also provides updates regarding the removal and discontinuation of certain BD Alaris Pump Infusion Sets.
The performance data and information in this letter replaces information previously communicated in BD field action MMS-25-5311.
Affected devices:
- Product Description: BD Alaris Pump Infusion Sets compatible with BD Alaris Pump Module Model 8100
- Software: BD Alaris with Guardrails Suite MX, versions up to v.12.6
BD stated that some Alaris Pump sets with restrictive components and designs (such as closed male luer, filters, check valves, Y-sites, microbore tubing, etc.) perform worse than previously disclosed. The deviations most commonly occur at low programmable rates under 1 mL/h and at or under 5 mL of “bolus volume”.
BD has continued to test BD Alaris Pump Infusion Sets to update infusion set performance data for accuracy. This testing found that the previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse.
As of August 19, 2026, BD has not reported any serious injuries or deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with clinical questions about this recall should contact BD Alaris Medical Affairs at Alarismedicalaffairs@bd.com. Customers in the U.S. with technical or customer service questions should contact BD Technical Support at 866-488-1408.
|
