BEUDAMED
    FDA Recall Open, Classified

    Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1

    Recall: Z-1272-2022 · Initiated April 18, 2022

    Recall

    Recall Number
    Z-1272-2022
    Event Number
    89913
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 18, 2022
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1

    Reason

    Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001

    Action

    The firm disseminated an URGENT MEDICAL DEVICE CORRECTION letter on 04/18/2022. The letter provides an overview of eight issues. These issues may result in pump alarm failure, falsely detected alarm failure, termination of active infusion, a state where the smart battery cannot provide its status to the pump, incorrect depleted battery alarm with interrupted infusion, abnormal internal clock behavior, pump run without the ability to terminate infusion via the Stop or Power keys, Program Volume Delivered (PVD) reset to zero, display of a false Rate Below Recommended Minimum for Syringe Size alarm, Pressure Increasing alarms occurring earlier than expected or false alarms with or without an occlusion present, display an incorrect value for the time remaining during a Bolus Dose or Loading Dose infusion while correctly infusing, and/or pump not communicating with PharmGuard Server (PGS).

    Distribution

    Worldwide distribution. US nationwide including US Virgin Islands, Countries of: AE, AL, AT, AU, BE, BM, BN, BS, CA, CH, CL, CY, CZ, DE, DK, DO, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IR, IT, KR, KW, LB, LK, MU, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, QA, SA, SE, SG, TR, TT, VI, and VN.

    Quantity

    65093 units