BD's Updated Infusion System Cleared After FDA Recall

All of the current Alaris devices in the U.S. market will be remediated or replaced with the updated 510(k) cleared version.

Bd Alaris Infusion System Product Shot

BD today announced that the updated BD Alaris Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), which enables both remediation and a return to full commercial operations for the most comprehensive infusion system available in the United States.

This clearance covers updated hardware features for Point-of-Care Unit (PCU), large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules. It also covers a new BD Alaris Infusion System software version with enhanced cybersecurity, along with interoperability features that enable smart, connected care with the most widely used electronic medical record (EMR) systems.

The BD Alaris Infusion System features a centralized user interface for up to four modules for all major types of infusions, including large volume pumps, syringe pumps, and PCA therapy with optional respiratory monitoring. Having one, comprehensive infusion system enables hospitals and health systems to easily scale their infusion needs across an entire integrated delivery network and provide interoperability with EMRs. With a common Point-of-Care Unit, one interface controls all modules, which is different from other pumps on the market that have non-modular architecture. The "one system" approach offers ease, simplicity and scalability.

The BD Alaris Infusion System can also feed data to the BD HealthSight™ platform for enterprise medication management, which is a unique combination of connective technologies, analytics and expert services that turn information into insights among caregivers and create seamless visibility across BD medication management solutions. With this platform, health systems can view infusion status in real-time as well as access an intuitive knowledge portal with actionable information related to clinician trends and drug and fluid libraries.

To address all open recalls and ensure all devices at customer sites are running the most recent version of the BD Alaris Infusion System Software, all of the current Alaris devices in the U.S. market will be remediated or replaced with the updated 510(k) cleared version. Given the large installed base of the BD Alaris Infusion System, BD will actively engage and start working in close partnership with its customers to undertake and complete the remediation or replacement of all devices in the field. 

BD has been preparing for the updated clearance and return to full commercial operations by investing in the proper operational capacity and functional capabilities to provide customers with the best experience possible. This includes investments to increase manufacturing capacity, strengthen supply chains and increase supplier redundancy to help the company meet its remediation obligations and continue to reliably supply infusion products to customers. BD also retained its infusion implementation and service teams while products were on ship-hold to ensure support for its customers during the pandemic and enable seamless execution upon clearance.