FDA Announces Several New Recalls of BD Alaris Pump Module Model 8100 Because of Key and Bezel Problems

April 22, 2021

On April 16, 2021, the U.S. Food and Drug Administration (FDA) reported (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) Care Fusion 303, Inc.’s, recall of the BD Alaris Pump Module 8100 because the device may experience stuck or unresponsive keys during operation. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

FDA Announces Recall of BD Alaris Pump Module Model 8100 Because of Risk of Stuck or Unresponsive Keys

The recall affects 145,492 devices of the BD Alaris Infusion Pump Module model 8100 with part numbers 49000239, 49000346, 49000438, and 49000439. The parts were manufactured between January 15–December 5, 2019 and distributed from January 23–December 5, 2019. The recall is separate from the BD Alaris Pump Module 8100 keypad recall dated August 4, 2020.

The manufacturer received 79 reports of the keypad lifting up after fluid entry, which led to unresponsive or stuck keys, resulting in infusion delay or interruption or preventing clinicians from changing fluid or medication infusions on the affected devices. Although it had no reports of injuries or death, high-risk patient populations who are receiving life-sustaining infusions are at the greatest risk of harm, because delays or interruption of infusions can cause serious injury or death.

On March 3, 2021, CareFusion 303, Inc., sent a new urgent medical device recall letter to all affected customers and provided the following instructions: 

Actions for Clinical Users

Actions for Cleaning Personnel

Actions for Biomedical Engineering

Actions for BD Alaris System Rental Providers:

Bezel-Related Recalls

On April 19, 2021, FDA also reported (https://www.fda.gov/medical-devices/medical-device-recalls/tenacore-recalls-alaris-pump-bezel-assembly-and-alaris-infusion-pumps-repaired-bezel-assembly-due) Tenacore’s February 25, 2021, recall of 474 BD Alaris System model 8100 devices and another related recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tenacore-llc-issues-nationwide-recall-tenacores-replacement-front-bezel-assembly-carefusion-alaris) of 2,001 of those devices because of two reports of cracks and separations in the bezel repair posts leading to:

FDA considers both Tenacore recalls class I as well.

On April 30, 2021, FDA reported (https://www.fda.gov/medical-devices/medical-device-recalls/pacific-medical-group-dba-avante-health-solutions-recalls-alaris-infusion-pump-module-8100-bezel-due) Pacific Medical Group's March 24, 2021, recall of 2,452 devices after 62 reports and one death involving the cracked bezel problems. It is a class I recall.

Consumers with questions about the recalls should contact BD at 888-562-6018, Monday through Friday between 7 am–4 pm (PT), or at SupportCenter@bd.com (mailto:SupportCenter@bd.com).

Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) they experienced using these devices to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.

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