BEUDAMED
    FDA Enforcement Class II Ongoing

    Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.

    Recall: Z-0653-2022 · Reported February 23, 2022

    Enforcement

    Recall Number
    Z-0653-2022
    Event ID
    89144
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 23, 2022
    Initiation Date
    December 3, 2015
    Classification Date
    February 17, 2022
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.

    Reason

    There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.

    Code Info

    Medfusion 3500 and 4000 Syringe Infusion Pumps manufactured between April 2012 and June 2015; and Medfusion 3010 and 3010A (and pump models 3500 and 40000 serviced during April 20121 and June 2015 in which a main board was replaced.

    Distribution

    Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.

    Quantity

    38,797 (31,065 pumps and 7,732 boards)