On April 16, 2021, the U.S. Food and Drug Administration (FDA) reported Care Fusion 303, Inc.’s, recall of the BD Alaris Pump Module 8100 because the device may experience stuck or unresponsive keys during operation. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
The recall affects 145,492 devices of the BD Alaris Infusion Pump Module model 8100 with part numbers 49000239, 49000346, 49000438, and 49000439. The parts were manufactured between January 15–December 5, 2019 and distributed from January 23–December 5, 2019. The recall is separate from the BD Alaris Pump Module 8100 keypad recall dated August 4, 2020.
The manufacturer received 79 reports of the keypad lifting up after fluid entry, which led to unresponsive or stuck keys, resulting in infusion delay or interruption or preventing clinicians from changing fluid or medication infusions on the affected devices. Although it had no reports of injuries or death, high-risk patient populations who are receiving life-sustaining infusions are at the greatest risk of harm, because delays or interruption of infusions can cause serious injury or death.
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–November 14, 2019, according to facility guidelines.
- Contact BD at 800-482-4822 to order replacement pump module keypad kits at no charge
- Dispose of all pump module door assembly replacement kits dated from January 15–November 14, 2019, according to facility guidelines.
- 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 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 888-562-6018.
- To schedule remediation of the affected devices at your facility, contact BD at 888-562-6018.
- A BD service technician will visit your facility and perform keypad replacements of affected devices at no charge.
- To order replacement pump module keypad kits at no charge and repair the devices internally at your biomedical engineering department, contact BD at 800-482-4822.
- 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.
Bezel-Related Recalls
On April 19, 2021, FDA also reported Tenacore’s February 25, 2021, recall of 474 BD Alaris System model 8100 devices and another related recall of 2,001 of those devices because of two reports of cracks and separations in the bezel repair posts leading to:
- Free flow of fluids to patient
- Over delivery or under delivery of fluids delivered to a patient
- Interruption of fluids delivered to a patient
- Device leaking
- Device component burning or smoking
- Power supply failure or malfunction
FDA considers both Tenacore recalls class I as well.
On April 30, 2021, FDA reported Pacific Medical Group's March 24, 2021, recall of 2,452 devices after 62 reports and one death involving the cracked bezel problems. It is a class I recall.
Consumers with questions about the recalls should contact BD at 888-562-6018, Monday through Friday between 7 am–4 pm (PT), or at SupportCenter@bd.com.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using these devices to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.