FDA Says BD Alaris Infusion Pump Problems Could Lead to Severe Injury, Death

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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Master Baby Food Lawsuit Filed in MDL Outlines How Toxic Metals Caused Autism, ADHD in Children
Master Baby Food Lawsuit Filed in MDL Outlines How Toxic Metals Caused Autism, ADHD in Children (Posted 2 days ago)

Plaintiffs have submitted a baby food lawsuit Master Complaint that is expected to streamline the filing of lawsuits alleging that toxic heavy metals in Beech-Nut, Gerber, Hain and Nurture products caused ADHD, autism and other developmental disorders.

Lawsuit Claims AGGA Device Damaged Teeth, Resulting in Disfiguring Injury
Lawsuit Claims AGGA Device Damaged Teeth, Resulting in Disfiguring Injury (Posted 2 days ago)

Another AGGA device lawsuit has been filed by a man who says he had to have the device surgically removed less than a year after having it implanted due to jaw problems and migraines.