BEUDAMED
    FDA Recall Terminated

    Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    Recall: Z-2554-2019 · Initiated October 15, 2018

    Recall

    Recall Number
    Z-2554-2019
    Event Number
    81283
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 15, 2018
    Terminated
    October 11, 2022
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    Reason

    Customers who utilize PharmGuard Server Software (PGS) with Medfusion 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion 4000 pumps.

    Action

    Smiths Medical notified customers on about 10/15/2018 via "URGENT MEDICAL DEVICE FIELD SAFETY NOTICE". Specifically, Biomed individuals (owners) at each facility were notified because they are in contact with Smiths Medical service and repair team to conduct the correction. Instructions included the following actions: 1. To determine if your facility has any devices with a duplicate wireless MAC Address, a software script must be run on the PGS Database to collect MAC Address and serial number information. The PGS Database must be at version 2.0, 2.1, or 2.2 for this data collection process to be completed. Refer to instructions on Attachment 1, Field Safety Notice Response Form, for available options to complete this data collection process, and if needed, to upgrade your PGS database and Medfusion 4000 device software/firmware. Please return the Response Form within 10 days of receipt of the Field Safety Notice. 2. If it is determined that any of your Medfusion 4000 pumps are affected by this issue, Smiths Medical Service and Repair will contact you to discuss repair options for the affected devices, based on the contact information provided on the Response Form. Questions regarding the notification can be sent to Smiths Medical via email at [email protected].

    Distribution

    Worldwide distribution - Nationwide in the states of AL, AR, AZ, CA, CN, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV and country of Canada.

    Quantity

    20,884 devices