The Alaris System is a vital signs monitoring system and infusion pump. It delivers medications, fluids, blood products, and blood to patients in certain amounts and are used in hospitals as well as other healthcare facilities. In February of 2020, Becton, Dickinson and Company and its subsidiary CareFusion 303 Inc. recalled the device. The Federal Drug Administration (FDA) identified this as a Class I recall. This means it is the most serious type of recall, as the use of these devices may cause serious injuries or death. Continue reading below to learn more and contact an experienced Texas medical device attorney if you were injured by this device.
What is the Reason for the Recall?
Becton, Dickinson and Company and its subsidiary CareFusion 303 Inc. recalled many of the Alaris pumps due to software errors, multiple system errors and use-related errors. According to the FDA’s notice, the models included in the recall earlier this year have errors that may lead to interruption of infusion, delay in infusion, slower medication delivery, and faster medication delivery.
For modules with software version 9.33 or earlier, the following issues may be present:
- Software/system errors
- Delay options programming
- Low battery alarm failures
- Keep vein open (KVO)/”End of Infusion” alarm priority
- Use-related errors related to custom concentration programming
For modules with software version 12.1.0, the following issues apply:
- Low battery alarm failures
- Keep vein open (KVO)/”End of Infusion” alarm priority
- Use errors related to custom concentration programming
- KVO Rate not available when using delay options programming
At the time of the FDA’s recall notice, there were 55 reported injuries and one death.
Who May be Affected?
The following parties may have been affected by the recall of defective Alaris System infusion pumps:
- Health care providers using the Alaris System
- Patients having infusions using the Alaris System
- Biomedical Engineering Staff that manage hospital systems
What Can I Do?
On February 4, 2020, Becton, Dickinson and Company and CareFusion 303 sent letters to customers stating they will contact all affected customers to begin the scheduling process for the software update when the software becomes available. Without it, the devices may remain vulnerable to the potential risk of multiple system and software errors. In addition to this, their notice also included certain recommendations to mitigate the risk of errors for consumers with both Alaris System Infusion Pump Systems Softwares until the matter is resolved.
Contact our Firm
If you or someone you know has been wrongly injured, you must not wait. Our firm is ready to help you through each step of the legal process to help ensure you recover the financial compensation you need to move on with your life. We are ready to help–all you have to do is contact Brock & Goetzmann, PLLC today.
