Field Safety Notice Draeger Medical Filter/HME TwinStar® Plus (ICN 2236)

MHRA: 5394600

NHS Supply Chain Reference: 41

Alert:

• The supplier Draeger Medical has issued an urgent Field Safety Notice following market surveillance regarding the Filter/HME TwinStar® Plus revealed cases of increased inspiratory resistance, resulting in insufficient ventilation, which may be related to the formation of condensation in the filter housing.
• Increased resistance carries the risk of desaturation for the patient. Should this hazardous situation occur, consider the possibility that it may be related to the occlusion of the filter due to condensation.
• Filter/HME TwinStar® Plus products are intended exclusively for single patient use no longer than 24 hours. Excessive condensation can significantly shorten the period for effective use of the Filter/HME TwinStar®.

Products Affected:

• See page three of the Field Safety Notice, Annex1 for full details of all affected devices.
• Please note a number of these products are available from NHS Supply Chain.
• Please see our useful links section to access the Product Complaint Form.
• See our Downloads ▼ section to access the product listing for further information on the affected and delisted product codes and Field Safety Notice Acknowledgement form.

Next Steps:                      

• Draeger Medical advises the current Filter/HME TwinStar® Plus instructions for use contain warnings related to condensation but that the instructions can be further improved and are currently working on an update.
• Until the revised instructions for use are available Draeger Medical advises you may continue using the Filter/HME TwinStar®Plus as long as both airway pressure and volume are permanently monitored and alarm limits for each patient are suitably selected. Change the filter in the case of resistance increase.
• Read and follow the full instructions in the Field Safety Notice.
• Add a copy of this Field Safety Notice to every box of Filter/HME TwinStar® Plus in your facility and ensure that all users of these products and other persons within your organisation or where you may have forwarded the devices are made aware.
• Complete the Field Safety Notice Acknowledgement form by emailing it to: SafetyNoticeUK.C.GB@Draeger.com
• Draeger Medical are updating the Filter/HME TwinStar® Plus Instructions for Use accordingly. Until the updated version of the Instructions for Use is available, they advise they will be adding this Important Safety Notice to each box of Filter/HME TwinStar® Plus.
• 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 distributors 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.