Field Safety Notice 3M Solventum Ranger High Flow and Irrigation Sets (ICN 2953)

NHSSC: 26

Alert:

• 3M and Solventum are notifying all customers and users regarding an update to the Instructions for Use (IFUs) with respect to flow rates and fluid temperature for the Ranger High flow sets and the Ranger Irrigation sets, as well as the user manuals for the corresponding warming units.
• There have been no changes to the design or composition of these products that prompted this notification.
• Devices may continue to be used considering the updated information provided.
• If the device is used at a flow rate outside of the updated information provided, there is a potential risk for the devices to administer the fluids at a lower temperature than indicated and cause a decrease in patient temperature. Under the dire circumstances of a massive rapid infusion where high flow rates outside of the updated ranges indicated below may be used, there is a potential for hypothermia. This risk remains remote and unlikely.
• 3M advise they have received no hypothermia-related complaints reported associated with the use of the devices.

Products Affected:

• Please refer to the product listing for full details of the products available through NHS Supply Chain.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Continue to use the products as indicated, considering the updated information provided.
• Keep this notice on hand until the updated IFUs and operator’s manuals are available.
• Complete and return by e-mail to fsca-emea@solventum.com the Acknowledgement Form, page 4 of the notice, indicating that the corrective action was understood and executed.

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