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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. The firm has identified these deviations in performance are connected to certain pump infusion set design features, such as filters and other in-line components. These features may impact the performance of flow rate accuracy and time to alarm, particularly at very low flow rates.
As of June 11, BD has not reported any serious injuries or deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact BD Alaris Medical Affairs at alarismedicalaffairs@bd.com or BD’s Technical Support at DL-US-INF-TechSupport@bd.com or 1-888-812-3229.
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