CareFusion 303, Inc. is recalling the Alaris Infusion Pump Module 8100 due to risk that the keys could become unresponsive or stuck, leading to an infusion delay or interruption. The Class I recall affects 145,492 devices in the United States that were manufactured between January 15, 2019 and December 5, 2019, and distributed between January 23, 2019 and December 5, 2019.
The infusion pump and vital signs monitoring system delivers fluids such as medications, blood or blood products into a patient’s body in a controlled way. The product issues can prevent clinicians from changing the fluid or medication infusions. Patients most in danger are high-risk patients who are receiving life-sustaining infusions, because delays or interruption of infusions can cause serious injury or death.
The FDA has received 79 complaints related to the device issue; no injuries or deaths have been reported. CareFusion sent a New Urgent Medical Device Recall letter to affected customers on March 3, instructing them to remove the pump from service if the keyboard shows signs of lifting, becomes unresponsive or stuck. They were instructed to continue infusion if administering a critical medication and to replace the PC unit once it is deemed safe.