MERLIN PATIENT CARE SYSTEM-PROGRAMMER (2017-10-11)

Starting date:

October 11, 2017

Posting date:

October 27, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-64948

• Reason
• Affected products

Affected products

MERLIN PATIENT CARE SYSTEM-PROGRAMMER

Reason

A new management tool has been developed for clinicians to monitor patients who have devices subject to the October 2016 lithium cluster advisory to provide earlier notification of abnormal battery performance that may lead to premature battery depletion due to lithium cluster induced shorts. This tool will provide notification to clinicians via Merlin.net and upon interrogation with the Merlin programmer to help identify voltage drops indicative of lithium clusters.

The tool will be rolled out as a two part upgrade. The first upgrade is to Merlin.net (not a medical device), followed by Merlin Patient Care System (PCS) Programmer when the applicable software testing has been completed.

Refer to prior medical device advisory October 2016 for corrective measures implemented in association with the original advisory. In addition, if a BPA alert is detected, explant of the device is required.

Affected products