FDA-Device2021-08-11Class II
Sharesource Connectivity Platform for Use with the Amia Automated PD System
BAXTER HEALTHCARE CORPORATION
Hazard
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
Sold states
Worldwide distribution - US Nationwide distribution and the country of Japan.
Affected count
1 unit
Manufactured in
25212 W Il Route 120, Round Lake, IL, United States
Products
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2173-2021Don't want to check this manually?
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