BD Alaris Infusion Pump Recall Issued For 774K Units Linked To Injuries, Death

Becton Dickinson is recalling more than 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.

The U.S. Food and Drug Administration (FDA) announced a BD Alaris infusion pump recall on March 6, indicating that the systems used to deliver fluids, medications, blood and blood products in controlled amounts may malfunction, resulting in delayed delivery, infusion interruptions, or administration of medication too fast or too slow.

The issue was first reported by the manufacturer on February 4, 2020, and was categorized by the FDA late last week as a class I medical device recall, indicating that continued use of the devices may result in severe harm to the patient or death.

Multiple system errors, software errors, and use-related errors have been reported in connection with the Alaris infusion pumps. Some examples of system errors include low battery alarm failures, errors related to custom concentration programming, and keep vein open/End of Fusion alarm priority issues.

Serious side effects have been reported connected to the recalled Alaris systems, including at least 55 injuries and one death.

This isn’t the first recall involving BD infusion pump problems, as the manufacturer removed more than 150 million Alaris infusion sets from the market last year, due to issues where the tube may collapse during use, leading to the risk of medication overdose to patients.

An infusion pump and vital signs monitoring system delivers fluids through an infusion tubing placed into a patient’s vein or through other avenues of administration. The recalled infusion pump systems are designed for use in adult, pediatric and neonatal care patients in hospitals and other healthcare facilities.

The recall involves the following model numbers:

• BD Alaris System PC Unit Model 8000, software versions 9.5 and prior
• BD Alaris System PC Unit Model 8015, software versions 9.33 and prior, and software version 12.1.0
• BD Alaris Pump Module Model 8100, software versions 9.33 and prior, and software version 12.1.0
• Alaris Syringe Module Model 8110, software versions 9.33 and prior, and software version 12.1.0
• Alarms PCA Module Model 8120, software versions 9.33 and prior and software version 12.1.0

The recall impacts pumps from all manufacturing lots and includes devices with distribution dates between July 2004 and October 31, 2019, including Alaris PC units with software version 9.33 and older, and distribution dates December 18, 2019 to January 23, 2020, for Alaris PC units with software version 12.1.0.

BD issued letters to customers regarding the recall and has begun working on a schedule to roll out the software update when it becomes available.

Until the software update is complete, the devices may continue to be vulnerable to the risk of system and software errors and pose a risk to patients. The company also issued documents for healthcare providers focusing on potential steps to take in the event of system or software errors.

Anyone experiencing side effects from the BD Alaris pumps are being encouraged to report the problems to the FDA’s MedWatch Adverse Event Reporting Program.