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.

Recalled Product

• BD Alaris Infusion Pump Module
• Affected Model Number: 8100
• Affected Parts: 49000239; 49000346; 49000438; 49000439
• Manufacturing Dates: 01/15/2019 to 12/05/2019.
• Distribution Dates: January 23, 2019 to December 5, 2019
• Devices Recalled in the U.S.: 145,492
• Date Initiated by Firm: March 3, 2021

Device Use

The BD Alaris Pump Module System is an infusion pump and vital signs monitoring system that consists of a PC Unit, the Guardrails Suite MX, and up to four removable infusion or monitoring modules (channels). The System is used to deliver fluids including medications, blood, or blood products, into a patient's body in a controlled manner. It is used in hospitals and other health care facilities.

Reason for Recall

CareFusion 303 Inc is recalling the Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry. This could lead to keys that become unresponsive or stuck (See Figure 1).  This may lead to an infusion delay or interruption 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 infusions can cause serious injury or death.

Figure 1: Image of Device Keypad Without Lifting Compared to a Keypad With Lifting

There have been 79 complaints regarding this device issue. There are no reports of injuries or death.

Please note, this recall is separate from the BD Alaris Pump Module 8100 keypad recall dated August 4, 2020.

Who May be Affected

• Health care providers using the affected Alaris Pump System
• Patients who receive fluids or medications delivered by the affected Alaris Pump systems

What to Do

On March 3, 2021, CareFusion 303, Inc. sent a New Urgent Medical Device Recall letter to all affected customers and provided the following instructions: 

Actions for Clinical Users:

• Remove the pump from service and send to your Biomedical Engineering staff if the Pump Module keypad shows signs of lifting, becomes unresponsive, or stuck. 
• Continue the infusion until it is safe to replace the PC Unit if you are administering a critical medication.
  • In an urgent situation, close the roller clamp on the IV administration set to stop an infusion.

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. Wring out the cleaning cloth to squeeze out excess fluid.
  • Do not spray fluids directly onto the device.
  • Remove the pump from service and send to Biomedical Engineering if Pump Module keypad lifting or stuck or unresponsive keys are observed.

Actions for Biomedical Engineering:

• For Remediation of Pump Module Door Assembly Replacement Kits:
  • Dispose of all Pump Module Door Assembly Replacement Kits dated from January 15, 2019 to November 14, 2019, according to facility guidelines.
    • Contact BD at 1-800-482-4822 to order replacement Pump Module keypad kits at no charge
• For Remediation of Pump Module Keypads:
  • Refer to "Attachment A" of the New Urgent Medical Device Recall letter for a list of affected serial numbers or visit bd.com/mms-21-3991.
  • Select one of the remediation options below:
    • To order replacement Pump Module keypad kits at no charge and repair the devices internally at your Biomedical Engineering Department, contact BD at 1-800-482-4822.
      • Once you have received and replaced your keypads, destroy all affected parts following your institution's processes for destruction.
    • To ship the devices back to BD for repair at no charge, Contact BD Alaris Support Center at 1-888-562-6018.
    • To schedule remediation of the affected devices at your facility, contact BD at 1-888-562-6018.
      • A BD service technician will visit your facility and perform keypad replacements of affected devices at no charge.
• 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 Inc New Urgent Medical Device Recall letter to customers who are currently renting BD Alaris System devices.

Contact Information

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.

Additional Resources

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.