Field Safety Notice Dräger ErgoStar Catheter Mounts (ICN 3143)

NHSSC: 80

Alert:

• Drager has issued a Field Safety Notice having been made aware of instances where cracks have formed in the hose of some specific ErgoStar catheter mounts.
• In cases where cracks appear during use, leakage will occur.
• Depending on the size of the leakage and the selected ventilation pressure, the ventilator anaesthesia device can compensate for this.
• If the leakage cannot be compensated for, ventilation is restricted, and the patient may experience desaturation/hypoxia.
• Ventilators conforming to ISO 80601-2-12 and anaesthesia devices conforming to ISO 80601-2-13 will generate visual and audible alarms according to the set alarm limits.
• Drager advise they have not been informed to date of any negative effects on the health of the affected patients. However, this cannot be completely ruled out if this happens again.
• Drager’s analysis is still ongoing. At this time, they cannot rule out, that the listed ErgoStar will exhibit cracks during use.

Products Affected:

• Four of the affected ErgoStar products are available from 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.
• Cease use and quarantine all affected ErgoStar devices.
• Complete Drager’s UK Customer Reply Form and email to: C.GB@Draeger.com
• Drager advise a suggested alternative: MPC – MP01850, NPC – FDC845, which is not affected by the current issue, and can be obtained free of charge to replace your current stock by contacting your Drager representative.
• Please note, this is not an identical item, but a comparable alternative. Please contact your local Drager Sales and Service representative for further information.
• Drager do not require the affected ErgoStar devices returning, they should be disposed in accordance with your local regulations.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession for disposal, including NPC and quantity. Your Customer Services Advisor will give you a unique CMS log number, which should be quoted if you require further assistance, including credit where free of charge replacements are not requested.

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 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.