—#156896

Product

Plum 360 Infusion System

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K141789, K161469
Affected lot / code info: Model No. 30010

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 ICUMedical7087@stericycle.com 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.

Recalling firm

Firm: ICU Medical Inc
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2017-06-15
Terminated: 2020-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.