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U.S. Department of Health and Human Services

Class 1 Device Recall Ivenix Infusion System

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  Class 1 Device Recall Ivenix Infusion System see related information
Date Initiated by Firm September 08, 2022
Date Posted October 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-0002-2023
Recall Event ID 90845
510(K)Number K183311  
Product Classification Infusion safety management software - Product Code PHC
Product Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004

version 5.2.0
Code Information UDI-DI: 00811505030122 version 5.2.0
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information Contact Matt Kuhn
847-550-5751
Manufacturer Reason
for Recall		 The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
FDA Determined
Cause 2		 Software design
Action On September 8, 2022, the company notified affected customers via phone call and emailed letter. Customers were instructed to do the following: 1. If a high priority Pump Problem alarm occurs, the LVP should be powered down by holding the power button for 10 seconds then releasing the power button so that the screen goes dark, then pressing the power button again to re-start the pump. Alternatively, if you have another LVP available, you may use it to resume infusion. 2. Inform potential users of the product within your organization of this notification. If your facility further distributes or transfers products amongst satellite sites or other locations, please disseminate this information accordingly. Fresenius Kabi has updated the software to rectify the condition. The updated software is currently available. Please schedule a service call at your earliest convenience to have it installed. Customer support: Ivenix_support@fresenius-kabi.com; 1-978-775-8100
Quantity in Commerce 4 instances
Distribution Domestic distribution to NJ and WI.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PHC and Original Applicant = Ivenix, Inc.
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