BEUDAMED
    FDA Recall Terminated

    Plum 360 Infusion System

    Recall: Z-3031-2017 · Initiated June 15, 2017

    Recall

    Recall Number
    Z-3031-2017
    Event Number
    77624
    Firm
    ICU Medical Inc
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 15, 2017
    Terminated
    April 17, 2020
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835

    Description

    Plum 360 Infusion System

    Reason

    Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.

    Action

    ICU Medical sent an Urgent - Medical Device Correction letter dated June 15, 2017, to all affected customers. The firm contracted with Stericycle for recall notification, response tracking, and effectiveness checks. The customer notification was also posted on icumed.com. The notification requested that consignees verify their unit is working and testing the CE Module. If the unit's CE Module is loose or a blank display occurs, customers are asked to record the S/N and contact ICU Medical Technical Service Support Center at 800-241-4002, option 4. If the unit is functional, return to service. If the unit powers down without an alarm notification, use another unit and contact ICU Medical Global Complaint Management at 800-441-4100. The firm will contact reporting consignees of correction scheduling when parts become available. Adverse reactions or quality problems related to this problem should be reported to FDA's MedWatch Adverse Event Reporting Program by mail, fax, or online. Consignees are advised to inform potential users within their organization of the recall and to complete the recall response form attached to recall notification. The completed response form can be returned by email to [email protected] or faxed to 855-544-4814. If product was distributed, ask customers to request them to contact Stericycle for a copy of recall notification at 855-544-4813.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    68,559 units