Blueriver and BD joined forces in 2014 as BD was in search of a partner who understood the importance of quality management and could assist with their initial 510K filing. Blueriver has been working closely with BD in medication management for more than 10 years, primarily focusing on testing infusion pumps. With the acquisition of CareFusion, BC now dominates the global infusion pump market. It's highly likely that, if one has received medication through an infusion, they have benefited from a pump made by BD.
As a leading manufacturer of devices and infusion pumps, BD is committed to enhancing connectivity in hospitals and healthcare facilities. Their unique BD Alaris Infusion System securely links patient modules, providing care teams with a comprehensive patient perspective. This innovative platform seamlessly integrates with the most widely used electronic medical record (EMR) systems, ensuring scalability and interoperability.
In May 2019, BD initiated a Class 1 recall of more than 150 million Alaris Pump Model 8100 infusion sets produced from May 2016 to March 2019 due to potential issues causing rapid medication delivery or operation while not in "running status." The recall resulted from non-uniform silicone thickness in the tubing, leading to tubing failure or blockage, associated with reported injuries, including serious ones. These recalls had a significant impact on the healthcare industry due to the market share BD has on devices and infusion pumps.
In response to the recalls, BD prioritized taking action to increase engagement and ensure the safe reprogramming of these devices.
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From that point, Blueriver's main goal was to assist BD in reintroducing their solutions to the market. They played a crucial role in resolving issues and facilitating the release of these solutions by supporting multiple 510K filings. This partnership has had a significant impact on the availability of essential healthcare resources by ensuring that only quality and safe devices enter hospitals.
“From day one, we've tried to embed in our employees what important work they're doing. It’s more than just testing and coding. It impacts not only community health, but it actually helps to save lives.”
Gabriel Apodaca I CEO, Blueriver
Blueriver's dedication to this project is evident as they have supported BD in three other 510K filings, addressing concerns raised by the U.S. Food and Drug Administration (FDA) regarding their devices. These actions were necessary to meet quality standards and ensure the safety of the devices in healthcare settings. Throughout the years, Blueriver has consistently provided assistance and support whenever needed, solidifying their commitment to BD and the success of their solutions.
“Since 2014, we have been a proud supporter of BD, working on some of the most mission-critical devices and projects, helping to create solutions that are Advancing the world of health™. Our teams understand the significance of the work we do, particularly when working with medical devices, and approach their projects with tremendous respect and an innovative spirit.”
Lindsey Nix I SVP Partner Success, Blueriver
“It's a wonderful thing to be able to work on something that helps drive an outcome in people's lives. If my dad and my uncle did not have those pumps, neither of them would be here. And those are just two cases, but there are hundreds of thousands of people that those pumps are supporting on a daily basis,” Apodaca said.
To address open recalls, BD will engage closely with customers to ensure remediation or replacement of devices in the field, prioritizing compliance and patient safety. The company's operational capacity investments will facilitate rapid distribution and comprehensive support for the BD Alaris Infusion System.