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 Pump Module and Pump Module Door Assembly Replacement Kits
- Affected Models:
- Model 8100 (Pump Module)
- Pump Module Door Assembly Replacement Kits, Part Numbers:
- Manufacturing Dates: December 1, 2016 to January 23, 2019
- Distribution Dates: December 1, 2016 to January 23, 2019
- Devices Recalled in the U.S.: 264,746
- Date Initiated by Firm: August 4, 2020
The Alaris System is an infusion pump and vital signs monitoring system.
The infusion pump module delivers fluids, medications, blood and blood products into a patient's body in controlled amounts. The fluids are provided through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is used in hospitals and other health care facilities.
Reason for Recall
BD/CareFusion 303 is recalling the BD Alaris Pump Module and Pump Module Door Assembly Replacement Kits because the keypad may have one or more keys that become unresponsive or stuck. This may lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected devices.
High-risk patient populations who are receiving life-sustaining infusions are at the greatest risk of harm. For these patients, delays or interruption of infusion can cause serious injury or death.
BD has received 976 complaints about this device issue. There have been no reported injuries or deaths.
Who May be Affected
- Health care providers using the BD Alaris System
- Patients who receive fluids or medications delivered by the BD Alaris System
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 Health Care Providers
If the if the pump module keypad becomes unresponsive or stuck, remove the pump from service and send it to your facility’s biomedical engineering staff. If a critical medication is being administered, continue the infusion until it is safe to replace the pump module. In an urgent situation, close the roller clamp on the IV administration set to stop an infusion.
BD and CareFusion sent letters with additional instruction for customers. These are linked in the resources section below.
Recall related questions
BD Recall Support Center
Phone hours: 7:00 AM to 4:00 PM Pacific, Monday – Friday
- FDA Medical Device Recall Database Entry
- BD Alaris Pump Module Model 8100 Recall Notification
- CareFusion 303/BD Letter to Customers
- BD Press Release
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.