BEUDAMED
    FDA Recall Terminated

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    Recall: Z-2204-2021 · Initiated February 25, 2021

    Recall

    Recall Number
    Z-2204-2021
    Event Number
    88170
    Firm
    BioMedical Equipment Service Co (BMES)
    FEI Number
    3009548038
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 25, 2021
    Posted
    August 6, 2021
    Terminated
    April 22, 2024
    Address
    2709 S Park Rd, Louisville, KY, 40219-3645

    Description

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    Reason

    Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

    Action

    Recall notification emails were sent to customers beginning 2/25/21. The emails stated the following: We have been notified by the FDA and our distributor about a voluntary part recall, to address potential performance concerns for a bezel part used in the service and repair of Alaris Pump Module 8100. The bezel part subject to this corrective action was used in the service and repair of the Alaris Pump Module 8100 between July 10, 2020 and February 18, 2021. The part is from a distributor and is not a BMES part. We have switched distributors since learning of the issue. While it's listed as a voluntary recall we do not consider fixing the issue voluntary. BMES will cover the replacement of all impacted bezel repair parts under this field safety corrective action. A detailed letter is attached with the specifics outlined below. Formal Letter Customer Response Form Images of Impacted bezel repair part List of Impacted repairs. Our records indicate that BMES performed service and repair, including the installation of the impacted part on (X) out of a quantity of (Y) Alaris 8100 repairs. Next Steps REad through the attached letter and complete the attached form titled attachment A within the attached letter and email it to our BMES Quality Assurance, Jesse Curry at [email protected]. After placing the potentially affected pump in quarantine, please contact Quality Assurance at 1-800-626-4515 or email Jesse Curry at [email protected] to schedule replacement of the impacted part. The letter attached to the emails, titled "URGENT: Voluntary Field Safety Corrective Action Bezel Repair Part for Alaris Pump Module Model 8100" provided additional details regarding the product issue and the associated health risks.

    Distribution

    The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA.

    Quantity

    718 potentially affected pumps