The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- BD Alaris™ Syringe Module; and BD Alaris™ PCA Module, Syringe/PCA Sizer Sensor Replacement Kit
- Model Number:
- BD Alaris™ Syringe Module Model 8110
- BD Alaris™ PCA Module Model 8120
- BD Alaris™ Syringe/PCA Sizer Sensor Replacement Kit P/N 122786
- Manufacturing Dates: March 1, 2010 to present
- Distribution Dates: March 1, 2010 to March 12, 2020
- Devices Recalled in the U.S.: 141,889
- Date Initiated by Firm: August 4, 2020
The Alaris™ System is an infusion pump and vital signs monitoring system. The infusion pumps deliver fluids, medications, blood and blood products into a patient's body in controlled amounts. The pump provides fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The device is used in hospitals and other healthcare facilities.
Syringe Module Model 8110 (left) and PCA Module Model 8120 (right); each attached to the Alaris PCU Module
Reason for Recall
BD/Carefusion 303 is recalling the Alaris™ Syringe Module and Alaris™ PCA Module because the Alaris PC units may display the incorrect syringe types and/or sizes. This could potentially result in delays in infusion, under-infusion, or over-infusion. If this occurs, this could lead to serious adverse events, including death.
There have been no reported injuries or deaths.
Who May be Affected
- Health care providers using the Alaris™ System
- Patients who may receive fluids or medications delivered by the Alaris™ System
- Biomedical Engineering Staff that manage hospital systems
What to Do
On August 4, 2020, BD/CareFusion 303, Inc. sent a letter to customers stating the Alaris pump models, issues and the following recommendations:
Actions for Clinical Users:
- Ensure that the displayed syringe manufacturer and syringe size correctly identify the installed syringe.
- Remove the device from service and send to your Biomedical Engineering staff for repair if the PC unit displays an incorrect syringe type and/or size.
Actions for Biomedical Engineering:
- Do not use Alaris™ Syringe Modules and Alaris™ PCA Modules displaying incorrect syringe type and/or size. The biomedical engineer should:
- Conduct a barrel clamp accuracy test as outlined in the "Preventive Maintenance" section of the BD Alaris™ System Maintenance - Software User Manual and replace syringe barrel clamp mechanism if required.
- Contact BD at 1-800-482-4822 to order a Syringe/PCA Sizer Sensor Replacement Kit at no charge, or
- Contact the BD Recall Support Center at 888-562-6018 to send the module to the BD Service Depot for repair at no charge.
- Continue to use the affected Syringe/PCA Sizer Sensor Replacement Kits until the release of an FDA cleared redesigned syringe barrel clamp mechanism.
- Complete and return the Customer Response Form to acknowledge receipt of recall notification and the recall instructions provided.
Actions for BD Alaris™ System Rental Providers:
- Provide a copy of the letter and enclosures to customers who are currently renting BD Alaris™ devices.
Consumers who have questions about this recall may contact BD by phone at (888) 562-6018, Monday through Friday between 7:00am and 4:00pm (Pacific Time) or by emailing SupportCenter@bd.com.
- Medical Device Recall Database Entry
- BD Alaris Syringe Module 8110 and PCA Module Model 8120 Recall Notification
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.