The Recall Desk
HighFDA (Devices)·Z-2174-2021·Announced 2021-08-11

AMIA Automated Peritoneal Dialysis System User Guide Contains Incorrect Operating Instructions

The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device user guide containing incorrect operating instructions for a critical peritoneal dialysis system. While no injuries or illnesses have been reported, the potential for harm exists if patients operate the device based on inaccurate instructions. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation has recalled the AMIA Sharesource User Guide distributed with the AMIA Automated Peritoneal Dialysis System due to inaccurate instructions. The guide incorrectly states in some locations that the Ultrafiltration (UF) volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain Mode, which would then allow the patient to end therapy or proceed to their last fill.

The recall affects approximately 5,101 units distributed worldwide, including throughout the United States and Japan. The manufacturer identified the documentation error and issued a Class II recall to ensure patients and healthcare providers have accurate operating information.

Patients using the AMIA Automated Peritoneal Dialysis System should contact their healthcare provider to verify the correct procedures for using the Ultrafiltration Limit setting and ending therapy. Baxter Healthcare Corporation is providing accurate information to correct the documentation error.

The recalled product

Product
Kaguya Automated Peritoneal Dialysis System
Manufacturer
BAXTER HEALTHCARE CORPORATION
Category
Medical Device — Peritoneal Dialysis Equipment
Hazard
  • documentation-error
  • instruction-error

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 (1)

  • Product Code T5C8500 (distribution in Japan only)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category