BEUDAMED
    FDA Recall Terminated

    Alaris Pump Module Model 8100

    Recall: Z-2736-2020 · Initiated June 30, 2020

    Recall

    Recall Number
    Z-2736-2020
    Event Number
    85954
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2020
    Posted
    August 6, 2020
    Terminated
    April 23, 2024
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    Alaris Pump Module Model 8100

    Reason

    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.

    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, [email protected]

    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

    Quantity

    1093588