BEUDAMED
    FDA Enforcement Class I Ongoing

    BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.

    Recall: Z-1309-2021 · Reported April 7, 2021

    Enforcement

    Recall Number
    Z-1309-2021
    Event ID
    87387
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 7, 2021
    Initiation Date
    March 3, 2021
    Classification Date
    April 1, 2021
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.

    Reason

    Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay

    Code Info

    Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15, 2019 to November 14, 2019.

    Distribution

    Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ

    Quantity

    160300