BEUDAMED
    FDA Enforcement Class II Terminated

    Plum 360 Infusion System, List number 30010.

    Recall: Z-0101-2018 · Reported November 22, 2017

    Enforcement

    Recall Number
    Z-0101-2018
    Event ID
    78312
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 22, 2017
    Initiation Date
    October 30, 2017
    Classification Date
    November 16, 2017
    Termination Date
    August 28, 2019
    Address
    600 N Field Dr, N/A, Lake Forest, IL, 60045-4835, United States

    Description

    Plum 360 Infusion System, List number 30010.

    Reason

    (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.

    Code Info

    All devices with software v15.10.00.010

    Distribution

    Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.

    Quantity

    21,461 devices