Amia Automated PD System - Cycler (2018-12-11)

Starting date:

December 11, 2018

Posting date:

January 9, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68646

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  Reason
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  Affected products

Affected products

Amia Automated PD System - Cycler

Reason

Baxter corporation has identified an issue with the software on Amia Automated PD System cyclers, which can cause shortened dwell times during a cycle-based therapy only. In Canada, there have been no reported incidents. This will only occur during a cycle-based therapy when the smart drain treatment option is selected by the patient. This issue does not impact the time-based or tidal therapy modes, which are the more commonly programmed modes of PD therapy within Canada.

Affected products