Class 1 Device Recall Alaris Pump Module Model 8100

• Date Initiated by Firm: June 30, 2020
• Date Posted: August 06, 2020
• Recall Status: Terminated on April 23, 2024
• Recall Number: Z-2736-2020
• Recall Event ID: 85954
• 510(K)Number: K133532
• Product Classification: Pump, infusion - Product Code FRN
• Product: Alaris Pump Module Model 8100
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
• FDA Determined Cause: Device Design
• Action: On 06/30/2020, Urgent Medical Device Recall Notifications were mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical Users: 1. Ensure back-up devices are readily available when infusing critical medications. 2. Follow the User Manual instructions on how to properly load the administration set into the Pump Module. 3. This issue will not cause a pump alarm so when beginning an infusion, and periodically during an infusion: a. Check the drip chambers for both primary and secondary infusions to ensure the drip rate correlates to the intended infusion rate. b. Know the expected duration of the infusion, and periodically check the amount of mediation/fluid remaining in the container. If the infusion seems to be running faster or slower than expected, immediately transfer the infusion to a different Pump Module. 4. If the pump module be dropped or severely jarred, immediately remove it from use and send it to biomedical engineering. Actions for Cleaning Personnel: During each cleaning open the door of each pump module and inspect the platen, hinges, and membrane frame for cracks or other damage. If damage is found, do not use the device and remove it from service and send to biomedical engineering. Actions for Biomedical Engineering: Expedite inspection. Verify the membrane frame assembly is not loose, and that the seal is not torn. Replace any platen or membrane frame assembly that is broken, cracked or damaged. If damage is found, do not use. Actions by Recalling Firm: Revised the Technical Service Manual and is offering a Medication Safety program. System rental providers, please provide a copy of this letter and enclosures to your customers who are renting affected devices. Recall resources/customer support: www.bd.com/alaris-system-hardware-recall Questions - Recall Support Center: 858-617-1316, GMB-AlarisMedSafetyProgram@bd.com
• Quantity in Commerce: 1093588
• Distribution: US: CA, FL, IN, TX, NC, LA, SC, VA, PA, OK, AZ, IL, KY, UT, AL, GA, TN, MA, MI, OH, AK, OR, MS, CO, NY, WI, KS, MO, MD, NV, AR, AS, ID, VT, NE, NJ, DC, HI, CT, MT, WV, NH, WA, DE, ME, NM, MN, WY, IA, SD, ND, MP, PR, GU. OUS: NL, MX, AU, MY, NZ, ZA, GB, FR, CH, CN, SG, TW, CA, IL, KW, QA, DE, BH, IN, SA, GI, AE, PK, PH, BE
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN