Class 1 Device Recall Alaris System PC Unit Model 8015

• Date Initiated by Firm: August 04, 2020
• Create Date: September 04, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2909-2020
• Recall Event ID: 85900
• 510(K)Number: K133532
• Product Classification: Pump, infusion - Product Code FRN
• Product: Alaris System PC Unit Model 8015
• Code Information: All serial numbers manufactured from April 07, 2017 to Present.
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
• FDA Determined Cause: Reprocessing Controls
• Action: On 08/04/20, Urgent Medical Device Recall notices were mailed to customers. Clinical Users: If the PC unit keypad becomes unresponsive or a key gets stuck, clinicians should remove the device from service and send to Biomedical Engineering. If you are administering a critical medication, continue the infusion until it is safe to replace the PC unit. Cleaning personnel can minimize the potential for fluid ingress during cleaning by 1) not using a cloth that drips, 2) wringing out the cleaning cloth to squeeze out excess fluid, and 3) not spraying fluids directly onto the device. Biomedical Engineering: If an affected PC unit has an unresponsive keypad or stuck key, remove the unit from service and call the recalling firm for information to order a replacement keypad or to send the module for repair at no charge. Until 510(k) clearance, the affected PC unit keypad design will continue to be provided for replacement or repair. 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 enclosed Customer Response Form. Provide a copy of this letter and enclosures to your customers who are currently renting affected devices. Recalling Firm is currently working on a design change for the PC unit keypad and will notify customers when replacement keypads are available. Firm will contact all affected customers to schedule remediation upon 510(k) clearance of the affected system, including the addition of the redesigned PC unit keypad. PC unit keypads on the affected units and replacement kits will be provided at no charge. Additional Information: Customer Advocacy, 888-812-3266, customerfeedback@bd.com; Training Resources www.bd.com/alaris-system-hardware-recall; Recall Support Center, 888-562-6018, SupportCenter@bd.com; Technical Support, 888-812-3229, DL-US-INF-TechSupport@bd.com; Customer Order Management, 1-800-482-4822, GMB-CTS-CustCareInfusion@bd
• Quantity in Commerce: 313740
• Distribution: U.S.:LA, FL, KY, MI, AL, GA, CA, TN, NC, TX, MA, OH, CO, WI, IL, KS, MO, UT, AK, MD, NY, NV, VA, NE, IN, PA, VT, DC, SC, CT, AR, NJ, MT, ND ,HI , NH, WA, DE, ME, OR, MN, AZ, MS, IA, NM, WY, ID, OK, SD, WV, MP, GU O.U.S.: CA, AE, AU, BE, CA, CH, IL, IN, KW, N/A, NL, NZ, PH, QA, SA, SG, TW, US, ZA
• 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.