Class 1 Device Recall BD Alaris Pump Module

• Date Initiated by Firm: March 03, 2021
• Create Date: April 01, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1309-2021
• Recall Event ID: 87387
• 510(K)Number: K133532
• Product Classification: Pump, infusion - Product Code FRN
• Product: BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
• Code Information: Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15, 2019 to November 14, 2019.
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
• FDA Determined Cause: Process design
• Action: On 03/03/2021, Medical Device Recall notices were mailed to customers including, Directors of Biomedical Engineering, Directors of Nursing, and Directors of Risk Management. Customers were asked to return the customer response form and were advised of the following: If you had previously remediated devices affected by the August 4, 2020 Pump Module Keypad Recall, those devices will not need to be remediated a second time, as a result of this recall. If Pump Module keypad lifting or stuck or unresponsive keys are observed, remove the pump from service and send to Biomedical Engineering. If a critical medication is being administered, continue the infusion until it is safe to replace the Pump Module. In an urgent situation, clinicians can close the roller clamp on the IV administration set to stop an infusion. Follow cleaning instructions provided in the current Directions for Use to minimize the potential for fluid ingress 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. All affected Pump Module Door Assembly Replacement Kits should be disposed per facility guidelines. Contact 1-800-482-4822 to order replacements. A list of affected pump module and pump module keypad serial numbers are posted on or bd.com/mms-21-3991 Select one of the remediation options below: 1): Order replacement Pump Module keypad kits at no charge and repair the devices internally. Contact 1-800-482-4822. After replacement, safely destroy all affected parts. 2): Ship devices back for repair at no charge, Contact Support Center at 1-888-562-6018. 3) Schedule remediation of the affected devices at your facility, contact 1-888-562-6018. A service technician will visit your facility and perform keypad replacements of affected devices at no charge. The root cause was identified as a supplier manufacturing process issue and has been resolved.
• Quantity in Commerce: 160300
• Distribution: Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = CAREFUSION 303, INC.