—#175374

Product

Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K161469
Affected lot / code info: All Plum 360 Infusers with software versions 15.10.00.010/.011/.012 and 15.11.00.017 when used with an ICU Medical MedNet CDL

Why it was recalled

A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.

Root cause (FDA determination)

Software change control

Action the firm took

On 8/1/2018 a "Urgent Medical Device Correction" letter was mailed to consignees via traceable mailing. The medical device correction letter informed consignees of the following: 1. To reduce the likelihood of the issue occurring at the bedside, you can consider not utilizing the option to "Force Pump to Accept Drug Library During Power Down" when finalizing the CDL with MedNet. In doing so, when powering down the infuser the clinician will have the option to install the CDL or not, based on the clinical situation. 2. ICU Medical will release a software update to correct the issue and will contact you when the update is available. 3. . Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular 4.Please inform potential users in your organization of this notification, complete the attached response form and return it to the fax number (1-888-628-6849 or e-mail address (ICUMedical3618@stericycle.com) on the form, even if you do not have the affected product. 5. For further inquiries, please contact ICU Medical using the information provided below: Global Complaint Management - 1-844-654-7780 or productcomplaintsPP@icumed.com Technical Support Center - 1-800-241-4002, option 4 or TSC.support@icumed.com

Recalling firm

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

Distribution

Distribution pattern: US nationwide distribution, and Canada

Timeline

Recall initiated: 2018-08-01
Posted by FDA: 2019-10-22
Terminated: 2021-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175374. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.