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U.S. Department of Health and Human Services

Class 2 Device Recall Plum 360 Infusion System with MedNet/ Smart Card Plug n Play Module

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 Class 2 Device Recall Plum 360 Infusion System with MedNet/ Smart Card Plug n Play Modulesee related information
Date Initiated by FirmAugust 01, 2018
Date PostedOctober 22, 2019
Recall Status1 Terminated 3 on April 27, 2021
Recall NumberZ-0171-2020
Recall Event ID 83480
510(K)NumberK161469 
Product Classification Pump, infusion - Product Code FRN
ProductPlum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Code Information 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
Recalling Firm/
Manufacturer		 ICU Medical Inc
600 N Field Dr
Lake Forest IL 60045-4835
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software change control
ActionOn 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
Quantity in Commerce47,152 devices
DistributionUS nationwide distribution, and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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