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U.S. Department of Health and Human Services

Class 1 Device Recall Ivenix Infusion System (IIS), LVP Software; LVPSW0005

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 Class 1 Device Recall Ivenix Infusion System (IIS), LVP Software; LVPSW0005see related information
Date Initiated by FirmJanuary 10, 2025
Date PostedFebruary 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1019-2025
Recall Event ID 96085
510(K)NumberK183311 
Product Classification Pump, infusion - Product Code FRN
ProductIvenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Code Information UDI-DI: 00811505030122. Software 5.9.2 and prior
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information ContactRebecca McCandless
847-393-5451
Manufacturer Reason
for Recall		Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
FDA Determined
Cause 2		Software Design Change
ActionFresenius Kabi began notifying consignees on 01/10/2024 via emailed letter. Consignees were instructed to check if your device contains the affected software, review and become familiar with the temporary Risk Mitigation actions for each anomaly outlined in the letter and notify customers/personnel if the product was transferred or further distributed. Additionally, to facilitate the installation of the pump software, LVP SW 5.10, your facility must install the new Ivenix Infusion Management System (IMS) software version (5.2) on your IMS server and install the new software version (5.10) for the Ivenix Large Volume Pump (LVP). Please post this letter in areas that affected devices are stored and used such that users of this device are aware of the issues and recommended risk mitigation measures. Lastly, consignees were requested to complete and return the Customer Reply Form.
Quantity in Commerce23 systems
DistributionUS distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
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 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) Database510(K)s with Product Code = FRN
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