Becton Dickinson (BD) CareFusion 303 Inc. is recalling certain lots of Alaris System Infusion Pumps due to system and software errors. The recall includes around 774,000 units. The U.S. Food and Drug Administration (FDA) has classified the recall as Class I, the most serious classification of recall. A Class I recall indicates that using the medical device may cause serious injury or death.
Alaris System Infusion Pump Recall Information
In February 2020, BD/CareFusion 303 announced a recall of Alaris PC units operating on software versions 9.33 and earlier. These units have manufacture dates between July 2004 and October 2019. Also, units with software version 12.1.0 are subject to the recall, with manufacturing dates between December 2019 and January 2020.
The Alaris PC units operate as an infusion pump and vital sign monitoring system. The infusion system delivers fluids, blood, blood products and medications to a patient through the controlled and monitored system. Patients who have an IV in a hospital setting most likely are connected to a similar infusion pump system. These units are used in hospitals and healthcare facilities across the world.
The recall follows a series of software and system errors, such as:
- Low battery alarm failure
- Delay options programming
- Keep vein open (KVO) alarm priority
- User-related errors
These errors can cause the system to work improperly. The system may delay or interrupt delivery of fluids or medication. Or, delivery may be faster or slower than what is needed. These events can cause serious harm to patients.
So far, the FDA reports 55 injuries and one death related to these errors.
Alaris Infusion Pumps Included in Recall
Healthcare providers and facilities should be mindful of the pumps that are subject to this recall. The recall includes the following Alaris models:
- 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
- Alaris Syringe Module Model 8110, software versions 9.33 and prior, and software version 12.1.0
- Alaris PCA Module Model 8120, 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.
BD/CareFusion 303 are contacting all customers. Software updates will be applied to the systems in order to resolve errors as soon as an update is available. Also, customers will receive information about how to mitigate errors and possible injuries.
Reporting Problems or Injuries
Consumers who have questions about the infusion pump recall, or who need to report a problem or injury, can contact BD/CareFusion 303 by calling 1-888-562-6018. Consumers can also email SupportCenter@bd.com.
In addition to contacting the company, consumers can also report adverse events to the FDA. This is done through MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Consumers can submit reports online, by mail or by fax.
Have You Been Injured by a Recalled Infusion Pump?
If you are suffering an injury due to one of the devices in this infusion pump recall, contact Drug and Device Watch. When medical devices are defective or malfunction, the manufacturer may be liable for any injuries that patients suffer. That means that injured patients may be able to pursue compensation for their injuries caused by a defective medical device.
If you have an injury and have an actionable legal claim, you may be able to recover compensation for your medical expenses, lost income, pain and suffering and more. Contact us to find out more about your rights and options. For a free legal consultation, call 1-888-458-6825. You can also email us using the contact form on our website.