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Completed

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

FDA Recall Z-1283-2024 · Posted 2024-03-11

Recalling FirmFresenius Kabi USA, LLC
Recall StatusCompleted
Product CodeFRN
Date Initiated2023-05-10
Product Quantity6 US

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution to the states of CA, CO, NJ, WI, UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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