BEUDAMED
    FDA Enforcement Class II Terminated

    Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.

    Recall: Z-0171-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0171-2020
    Event ID
    83480
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    August 1, 2018
    Classification Date
    October 22, 2019
    Termination Date
    April 27, 2021
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835, United States

    Description

    Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.

    Reason

    A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.

    Code Info

    All Plum 360 Infusers with software versions 15.10.00.010/.011/.012 and 15.11.00.017 when used with an ICU Medical MedNet CDL

    Distribution

    US nationwide distribution, and Canada

    Quantity

    47,152 devices