BEUDAMED
    FDA Recall Terminated

    Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.

    Recall: Z-0242-2016 · Initiated October 1, 2015

    Recall

    Recall Number
    Z-0242-2016
    Event Number
    72331
    Firm
    WalkMed Infusion, LLC
    FEI Number
    3000204189
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 1, 2015
    Posted
    November 6, 2015
    Terminated
    July 12, 2016
    Address
    6555 S Kenton St, Ste 304, Englewood, CO, 80111-6838

    Description

    Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.

    Reason

    The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.

    Action

    A Field Notification (letter) was provided to users on 10/01/15 to remind them of the following:use air elimination filters, as appropriate, not to over program into the device the volume to be infused, remove air from the IV bag prior to starting the infusion, issues associated with the use of Venofer or similar drugs. No products are being returned.

    Distribution

    Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA.

    Quantity

    4695 units