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™ PC Unit Model 8015, PC Unit Front Case with Keypad Replacement Kits
- Affected Models:
- BD Alaris PC Unit 8015
- Affected Keypads Replacement Kits:
- TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS
- TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2
- TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2
- TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS
- TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
- Manufacturing Dates: April 7, 2017 to June 15, 2020
- Distribution Dates: April 12, 2017 to June 25, 2020
- Devices Recalled in the U.S.: 305,526
- 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.
Reason for Recall
BD/CareFusion 303 is recalling the Alaris™ PC unit and PC Unit Front Case with Keypad Replacement Kits because the keypad may have one or more keys in the keypad that become unresponsive or stuck. This could lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected device.
Use of the affected product may cause serious adverse events, including death.
There have been 1,186 complaints about this device issue and one reported injury. There have been no reported deaths.
Who May be Affected
- Health care providers using the affected Alaris System
- Patients who receive fluids or medications delivered by the affected Alaris systems
What to Do
On August 4, 2020, BD/CareFusion 303, Inc. sent an Urgent Medical Device Recall notice to all affected customers and provided the following instructions:
Actions for Clinical Users:
- Remove the device from service and send to your Biomedical Engineering staff if the PC unit keypad becomes unresponsive or a key gets stuck.
- Continue the infusion until it is safe to replace the PC Unit if you are administering a critical medication.
Actions for Cleaning Personnel:
- Follow the cleaning instructions provided in the current Instructions for Use to minimize the potential for fluid entry during cleaning.
- Do not use a cloth that drips. Be sure to wring out the cleaning cloth to squeeze out excess fluid.
- Do not spray fluids directly onto the device.
Actions for Biomedical Engineering:
- Remove the unit from service if the PC unit has an unresponsive keypad or stuck key.
- Contact BD at 1-800-482-4822 to order a replacement keypad at no charge or call the BD Recall Support Center at 1-888-562-6018 to send the module to the BD Service Depot for repair at no charge.
- Be aware, the affected PC unit keypad design will continue to be provided for replacement or repair until the release of an FDA cleared redesigned PC unit keypad.
- Inspect all PC unit keypads for bubbling, cracks, damage, layer separations, and holes. Replace the front case keypad if it fails inspection.
- Complete and return the Customer Response Form to acknowledge receipt of the notification and the recall instructions.
Actions for BD Alaris™ System Rental Providers:
- Provide a copy of the CareFusion 303/BD Letter to Customers.
- Enclose the letter to customers who are currently renting BD Alaris™ System devices.
Consumers with 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.
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.