Field Safety Notice Edwards Lifesciences TruWave Disposable Pressure Transducers, FloTrac Sensors and Acumen IQ Sensors (ICN 2322)

Alert:

• Edwards Lifesciences is voluntarily notifying customers of an issue regarding certain Lots of TruWave Disposable Pressure Transducers (DPTs), FloTrac Sensors and Acumen IQ Sensors.
• Edwards Lifesciences recently received customer complaints noting flushing difficulties during setup of the devices listed in the Field Corrective Action #181. The investigation revealed a manufacturing issue causing a potential occlusion within certain devices. Some devices were fully occluded and could not be flushed, while other devices were partially occluded causing slower flushing.
• Edwards LifeSciences data indicates the issue potentially occurs in 3% of affected Lots.

Products Affected:

• A number of these products are available from NHS Supply Chain. However, Edward Life Sciences confirm only four products have been supplied to NHS Supply Chain warehouses with affected Lot numbers please refer to the attachment for full details.
• Stock in our warehouses has been checked and we can confirm that current stock holding is not of any of the affected Lot numbers. Future deliveries will be of different, unaffected Lot numbers.

Next Steps:                    

• Read and follow the full instructions in the Field Corrective Action Notice and share with all users of the affected products.
• If you experience flushing difficulties, please use a new device.
• This may cause a procedural delay.
• Edward Life Sciences advise there is no anticipated patient harm due to the issue as it is detected prior to use when flushing the device, per the Instructions for Use (IFU).
• If you prefer to return any unused, impacted devices purchased though NHS Supply Chain please contact your local Customer Service Advisor who will organise a code 8 “Not to Specification” return for credit. All products to be returned no later than Friday 8 December 2023.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

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

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.