Following a number of BD Alaris infusion pump recalls, federal health officials warn problems with the design ocould result in severe injury or death for patients.
On September 21, the FDA gave four recent Becton Dickinson infusion pump recalls Class I and Class II designations after determining that hardware defects could prevent or delay treatment to patients.
Becton Dickinson and Company initially announced the recalls last month, after acknowledging a variety of Alaris infusion pump problems, including malfunctioning keypads, incorrect module types and sizes, and channel errors, all of which could create a situation that delays or prevents the pump from operating as expected.
The systems deliver fluids and medications through an infusion tubing placed into a patient’s vein or through other avenues of administration. The recalled pumps are designed for use in adult, pediatric and neonatal care patients in hospitals and other healthcare facilities.
The FDA gave three of the four recalls as Class I designations, indicating they are the most serious of their kind and warning of a reasonable probability the use of the products may result in serious or potentially fatal outcomes. The Class II recall status is a lesser severity designation, but still indicates the use of the product may cause temporary or medically reversible adverse health consequences.
The FDA’s announcement categorized both the BD Alaris PC Unit 8015 models manufactured from April 7, 2017 to present, and the BD Alaris Pump Module 8100 models manufactured from December 1, 2016 to January 23, 2019 as Class I recalls. Both of these units were found to exhibit unresponsive or stuck keys as a result of fluid ingress, potentially resulting in a delay to the start of infusion or interruption of infusion.
The third Class I designation involves BD Alaris Syringe Module Model 8110 and PCA Module 8120 models, due to the potential for the Alaris PC unit to display incorrect syringe types and syringe sizes. Officials warn this defect could also result in a delay of treatment, but could also cause an under or over-infusion of fluids.
The fourth recall involving BD Alaris EtCO2 Module 8300 models manufactured from January 5, 2018 to January 4, 2019 was given a Class II designation. These devices were found to contain an EtCO2 Module issue that may result in a CHANNEL ERROR, causing a delay or interruption of patient monitoring.
The FDA’s classifications do not change the guidance issued by the manufacturer provided in the initial recalls. Medical professionals and patients are being asked to report any adverse reactions or experiences with the recalled devices to the FDA’s MedWatch Program.
The series of recalls comes just months after a BD Alaris infusion pump recall affecting 774,000 infusion pumps distributed to hospitals and medical facilities nationwide, due to software errors that have been linked to dozens of injuries, and at least one death.
In 2019, Becton Dickinson was forced to remove more than 150 million Alaris infusion sets from the market due to issues where the tube may collapse during use, leading to the risk of medication overdose to patients.