Field Safety Notice Armstrong Medical Anaesthetic Circuit, AquaVENT® CPAP System and Ventilator Circuit for Non-Invasive Ventilation (ICN 3214)

NHSSC: 96

Alert:

• Armstrong Medical has issued a Field Safety Notice, CF-1573, to inform users of an update to the Instructions for Use (IFU) for Anaesthetic Circuits, AquaVENT® CPAP Systems and Ventilator Circuits for Non-invasive Ventilation devices.
• The IFU update follows receipt of seven (7) reports from customers stating that there have been tears occurring between the tubing and the purple cuff connector when disconnecting to replace the filter, resulting in a delay to treatment and/or the need to replace the entire circuit.
• Armstrong Medical advise their investigation did not identify any anomaly or non-conformance with the product as all devices were manufactured to and met specification.
• The update to the IFU for the affected devices includes the following:
  • Do not disconnect the circuit by pulling on the tubing. Always disconnect by holding the purple cuff connector and pulling the breathing filter gently
  • When connecting a breathing filter do not push excessively in to the purple cuff connector. Push to the point of resistance and ensure the breathing filter can be easily attached and detached from the breathing circuit/tubing during setup before proceeding.

Products Affected:

• 12 products currently or previously supplied by NHS Supply Chain are affected.
• Please see the attached product listing and Field Safety Notice for more information and details on the affected products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• All devices identified should continue to be used in line with the updated IFU as detailed in the Field Safety Notice.
• Complete the Response Form, found page 3 of the notice, and return to: regulatoryaffairs@eakinhealthcare.com.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.