Field Safety Notice Nikkiso Aqualine, Aquaset and Citraset Tubing Sets and Filters (ICN 2609)

Alert:

• Nikkiso has issued a Field Safety Notice following discovery during product surveillance of a potential problem which could affect product performance.
• The membrane of the four pressure domes, (access pressure dome, pre-filter pressure dome, return pressure dome and filtrate pressure dome) may have a visible hole in the surface in a core position. See figures one and two, pages four and five of the Field Safety Notice.
• The presence of a hole may cause any of the following issues, leakage of liquid during priming, blood during treatment, or allow air in the circuit.
• Any of the above hazards could cause delay in treatment delivery due to the need for changing the tubing set, A reduction in therapy effectiveness, blood loss during treatment or contamination to the patient or end user.

Products Affected:

•  Six of the products affected are available on the eDirect route from NHS Supply Chain:

• Please refer to the Field Safety Notice for details of the affected manufacturing dates.

Next Steps:

• Nikkiso confirm the cause of the issue has been identified and action is being taken to rectify.
• Until unaffected products are available users are advised to follow the Field Safety Notice this includes carrying out a visual check under a light source.
• If the hole is detected the device should not be used. A new tubing set should be used following the same visual checks.
• All affected unused devices should be returned to Nikkiso, please contact your local Nikkiso Representative or email: alyall@nikkisomedical.com to organise collection and return.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of all affected devices being collected by Nikkiso to enable us to record and offer assistance as appropriate.
• Please note this is not a product recall, the product can continue to be used subject to this additional check.
• Nikkiso advise their UK Business Unit Manager is managing this issue and already in contact with all affected customers.

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.