FDA-Device2024-03-20Class II
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Fresenius Kabi USA, LLC
Hazard
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
Sold states
US Nationwide distribution in the states of WI and NJ.
Affected count
3
Manufactured in
50 High St Ste 50, N/A, North Andover, MA, United States
Products
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1282-2024Don't want to check this manually?
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