BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 3, 2015

    Recall

    Recall Number
    Z-0653-2022
    Event Number
    89144
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    December 3, 2015
    Posted
    February 17, 2022
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    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.

    Action

    The firm issued Customer Information Bulletin dated 03-Dec-2015. It explained the details of the issue and provides the consignee a list of serial numbers for pumps in their facility that may be impacted. In addition, it informs the consignee if they have purchased main boards between April 2012 and June 2015 for part numbers G6000361, G6000435, G6001260, G6001560 and G6002728, they are included in the enclosed file. The consignee is to contact the recalling firm to make arrangements to begin the replacement process. If the Supercap Post alarm or the Backup Audible Alarm error code occurs prior to replacement, the consignee is to immediately remove the pump from service for repair by a trained biomedical technical at the recalling firm or at their facility. If the device with the affected serial number is sent to the recalling firm for any other unrelated repair, the supercapacitor will be replaced at that time. No response form was enclosed with the bulletin.

    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)