Recalls

Overview

BD Alaris Pump Module Model 8100 by CareFusion 303: Class I Recall – Due to Risk of Stuck or Unresponsive Keys

Recall Information

FDA

ISSUE: CareFusion 303 is recalling the Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry. This could lead to keys that become unresponsive or stuck. This may lead to an infusion delay or interruption or prevent clinicians from changing fluid or medication infusions on the affected devices.

High-risk patient populations who are receiving life-sustaining infusions are at the greatest risk of harm. For these patients, delays or interruption of infusions can cause serious injury or death.

There have been 79 complaints regarding this device issue. There are no reports of injuries or death.

Please note, this recall is separate from the BD Alaris Pump Module 8100 keypad recall dated August 4, 2020.

For more information on recommendations, please visit: https://www.fda.gov/medical-devices/medical-device-recalls/carefusion-303-inc-recalls-bd-alaris-pump-module-model-8100-due-risk-stuck-or-unresponsive-keys?utm_medium=email&utm_source=govdelivery