BEUDAMED
    FDA Recall Open, Classified

    ICU Medical Plum Solos, Item number 400011001; infusion pump

    Recall: Z-1991-2025 · Initiated April 22, 2025

    Recall

    Recall Number
    Z-1991-2025
    Event Number
    96777
    Firm
    ICU Medical, Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 22, 2025
    Posted
    June 18, 2025
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835

    Description

    ICU Medical Plum Solos, Item number 400011001; infusion pump

    Reason

    Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

    Action

    ICU Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 05/02/2025 via hand delivery. The notice explained the issue, potential risk, and requested the following: Actions for Users: 1. Identify all affected infusion pumps in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification. 2. If Maximum Dose Limit is not used for a medication, the issue will not occur. If Maximum Dose Limit is used for a medication, users should take the following precautions. If you need to adjust the weight or BSA, first clear the program and then reprogram. For further inquiries: To report adverse events or product complaints: Global Complaint Management - 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or [email protected]. For any questions regarding this action: Device Correction Inquiries https://icumed.custhelp.com/app/market-action. Additional technical information or assistance: Technical Support 1-(800)-241-4002, option 3 or [email protected].

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.

    Quantity

    214 units