Dive Brief:
- BD has expanded a Class I Alaris recall to cover 15 additional pump infusion sets, the company said Friday. The Food and Drug Administration posted the company’s notice on Monday.
- The company added the infusion sets to the recall after internal testing found variations in pump performance could result in patient death or serious adverse events.
- BD has not received any complaints related to the issue. The 15 additional sets were previously discontinued and BD is advising healthcare professionals to use other devices when available. BD said that while the infusion sets are discontinued, there may still be some in customers’ inventories.
Dive Insight:
The company wrote to customers on July 8 to flag potential performance problems when the BD Alaris Pump Module model 8100 is used with a subset of compatible pump infusion sets. BD expanded the recall on July 17. Last week, the company provided another update to expand the recall to cover more pump infusion sets.
BD warned that the impacted infusion sets could deliver fluid or medication at a higher or lower rate than prescribed. Other risks include delays to alarms about blockages and the unintended delivery of a sudden large volume of fluid or medication once a blockage is cleared.
The company said that the severity and nature of the health effects caused by the delivery problems will depend on the liquid being delivered and the condition of the patient. Vulnerable patient populations such as neonates and critically ill patients are at higher risk of serious adverse events or death, BD said.
BD is advising facilities with affected devices to use alternate Alaris pump infusion sets when available and clinically appropriate. If supplies of alternate sets are limited, BD is recommending that healthcare providers prioritize them for use in critical care, neonatal, infant, and pediatric cases.
Sites without alternate BD Alaris pump infusion sets should consider using the BD Alaris Syringe Module. If neither infusion sets nor syringe modules are available, BD said the recalled devices may be used with caution and enhanced clinical monitoring.
The devices covered by the expanded recall are among the Alaris products that BD discontinued last year as part of the simplification of its portfolio. BD took the action amid a broader push to drive growth of the Alaris franchise in the aftermath of the quality problems it faced in 2020 and its relaunch of the line in 2023.
CEO Tom Polen provided an update on the relaunch early this month at an investor event.
“We committed to upgrade the entire 2.2 million fleet of Alaris within the 3-year window. That was a commitment we made to the FDA when we returned to market,” Polen said at a Wells Fargo event. “We're in the second full year now, wrapping that up, and we're very much on track to complete the upgrade within the 3-year commitment. At the same time, we're back to gaining share.”
