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Sharesource Connectivity Platform

BAXTER INTERNATIONAL INC. · Model 5C9400 · UDI-DI 55413765565699

FKX Prescription

510(k) clearances

164,763

Adverse events (3,441 deaths)

Recalls

Facilities

Description

Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Amia APD System.

Recalls

Date	Firm	Reason
2025-08-28	Vantive US Healthcare LLC	Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the a
2023-11-15	Baxter Healthcare Corporation	There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
2023-10-24	Fresenius Medical Care Holdings, Inc.	Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
2023-02-22	Baxter Healthcare Corporation	The electrical safety testing was not properly performed on the impacted devices and additional testing is required
2022-04-21	Baxter Healthcare Corporation	Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
2021-06-30	BAXTER HEALTHCARE CORPORATION	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 U
2021-06-30	BAXTER HEALTHCARE CORPORATION	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 U
2021-04-28	Fresenius Medical Care Holdings, Inc.	Exposed to freezing temperatures due to refrigerated truck malfunctions
2020-09-12	Fresenius Medical Care Holdings, Inc.	The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid
2019-05-29	Fresenius Medical Care Renal Therapies Group, LLC	Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into t

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.