BD Alaris pump module model 8100 and the Alaris pump module door assembly replacement kits (part numbers 49000346, 49000239, 49000438 and 49000439) were included in the Aug. 4 recall. Those models and parts were manufactured and distributed between Dec. 1, 2016 and Jan. 23, 2019.
The recall was initiated because the keypad for the module and its door assembly replacement kits may have one or more keys that become unresponsive or stuck, which could lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected devices, according to an FDA release.
High-risk patients receiving life-sustaining infusions are at the greatest risk of harm, as delays or interruptions during infusion can cause serious injury or death.
BD has recalled 264,746 devices in the U.S. So far, the company has received 976 complaints about the device issue, with zero injuries or deaths reported at this time.
Users are urged to remove affected pumps from service if a module keypad becomes unresponsive or stuck, then send it to the facility’s biomedical engineering staff. If a critical medication is being administered, continue the infusion until it is safe to replace the pump module. In an urgent situation, close the roller clamp on the IV administration set to stop an infusion.
Last month, the FDA labeled the Aug. 4 recall of the BD Alaris PC unit 8015 and five affected keypad replacement kits as Class I after those keypads experienced the same issues with stuck or unresponsive keys.