Field Safety Notice TSC Life Fluido Trauma Standard Sets VCB522 (ICN 2656)

MHRA TBC

NHS Supply Chain Reference: 42

Alert:

• The supplier TSC Life have issued a Field Safety Corrective Action (FSCA) Notice following quality control testing which revealed a proportion of the tested samples to have elevated levels of non-toxic particulates in Fluido® single use sets.
• The presence of elevated levels of non-toxic particulates were present in quantities which exceed maximum allowable thresholds. These non-toxic particulates may enter the blood and fluid warming system and therefore could enter the patient’s bloodstream.
• This FSCA Notice is intended to mitigate any potential risks to patients and ensure compliance with relevant standards and regulations.
• TSC International B.V. advise they have received no complaints, or reports of injury or death associated with this issue.

Affected Products:

•  One of the products affected is available from NHS Supply Chain:

• There are no specific lot numbers impacted. This Field Safety Notice applies to all non-expired products.
• Please note that this is an advisory notification and not a product removal.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Before IV fluid administration of Fluido® Trauma sets (671500) and Standard sets (671200) the Extended Priming instructions provided in Annex l, page 4 of the Notice, must be followed.
• Acknowledge receipt of the Field Safety Corrective Action Notice and extended priming instructions by returning the acknowledgement form provided in Annex ll, page 3 of the notice to: fsca@tsc-life.com.

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.