BEUDAMED
    FDA Recall Terminated

    Plum 360 Infusion System, List number 30010.

    Recall: Z-0101-2018 · Initiated October 30, 2017

    Recall

    Recall Number
    Z-0101-2018
    Event Number
    78312
    Firm
    ICU Medical Inc
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 30, 2017
    Terminated
    August 28, 2019
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835

    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.

    Action

    The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues.

    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