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U.S. Department of Health and Human Services

Class 2 Device Recall Ivenix Infusion System (IIS), LVP Software

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  Class 2 Device Recall Ivenix Infusion System (IIS), LVP Software see related information
Date Initiated by Firm May 10, 2023
Date Posted March 11, 2024
Recall Status1 Completed
Recall Number Z-1283-2024
Recall Event ID 93968
510(K)Number K183311  
Product Classification Pump, infusion - Product Code FRN
Product LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Code Information UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information Contact Rebecca McCandless
847-550-2913
Manufacturer Reason
for Recall		 Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
FDA Determined
Cause 2		 Software design
Action Both issues were resolved through an update of the software to Version 5.8.0, which was installed at customer sites between May and August 2023. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product.
Quantity in Commerce 6 US
Distribution US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = Ivenix, Inc.
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