Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2173-2021·Announced 2021-08-11

Amia Automated PD System User Guide Incorrectly Describes Ultrafiltration Limit Function

Baxter's user guide for the Amia Automated PD System incorrectly describes how the Ultrafiltration Limit setting controls the Extra Last Drain Mode. This documentation error could affect patients' ability to properly end therapy sessions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II medical device recall involving a documentation error with no reported illnesses or injuries. The hazard is informational and operational in nature rather than a physical device defect, consistent with the rubric criterion of 'minor labeling errors.'

Plain-English summary

Baxter Healthcare Corporation has issued a recall of educational materials related to the Amia Automated PD System Sharesource Connectivity Platform. Specifically, the AMIA Sharesource User Guide contains a documentation error in its description of the Ultrafiltration (UF) Limit setting.

The guide incorrectly describes the function of the UF Limit setting as the ending criteria for the cycler's Extra Last Drain Mode. According to the recall notice, the guide states in multiple locations that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, which would allow the patient to end therapy or proceed to their last fill. This characterization of the UF Limit function is inaccurate.

The affected materials were distributed worldwide, including throughout the United States and Japan. Patients using the Amia Automated PD System and healthcare providers should consult updated documentation or contact Baxter Healthcare Corporation for corrected information about the UF Limit setting and Extra Last Drain Mode operation.

The recalled product

Product: Sharesource Connectivity Platform for Use with the Amia Automated PD System
Manufacturer: BAXTER HEALTHCARE CORPORATION
Category: Medical Device — Peritoneal Dialysis
Hazard: labeling-error
operational-risk
Affected units: 1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Product Code 5C9400
UDI: 45413765565692
55413765565699

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by BAXTER HEALTHCARE CORPORATION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · BAXTER HEALTHCARE CORPORATION

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