The expansion builds on a voluntary recall expanded earlier this year, informing customers of worst-case performance instances. Under certain cases, the pump, when used with a subset of compatible infusion sets, fails to perform as compared to the performance described in its user manual, according to a news release.
BD’s update includes an expansion of 15 additional impacted pump infusion sets included in the recall, plus new corrective actions and risk information. The company discontinued the 15 additional sets but they may remain in inventory based on their expiration date.
Franklin Lakes, New Jersey-based BD identified the issue through internal testing. It attributes deviations in performance to the pump infusion sets’ design features, such as filters and other in-line components. To date, it reports zero complaints associated with the issue. However, the affected products could lead to patient death or serious adverse events. The issue poses a particularly high risk to vulnerable patient populations such as neonates and critically ill patients.
The FDA designated the recall as Class I, its most serious kind.
Variations in pump performance with the issue could impact infusion delivery in multiple ways. Those include flow rate and loading bolus dose accuracy, upstream and downstream alarm delay and post-occlusion bolus volume over infusion. These issues could adversely impact infusion performance and dose accuracy.
Products included in the recall were distributed in the U.S., Canada, Belgium and South Africa.
More about the BD Alaris system
The Alaris system faced a series of issues over the past few years, going back to a Class I recall in early 2020. That recall centered around multiple system errors, software errors, and use-related errors. It led to a long-term shipping hold enacted that year.
BD cut its financial outlook for 2020 after initiating the shipping hold. The company applied for a new FDA clearance for the pumps in April 2021. It started a remediation effort in July 2021.
In August 2022, a federal judge in New Jersey ruled that a lawsuit against BD over how it communicated company performance amid its Alaris problems may proceed.
BD resumed Alaris distribution after receiving updated FDA clearance in July 2023. Last December, BD reached an agreement with the SEC to resolve an investigation related to its Alaris system. It agreed to pay $175 million to the SEC. That added to an $85 million settlement to resolve a class action suit in New Jersey about a year prior.
