Field Safety Notice Drager Filter/HME Slow Increase of CO2-Curve (ICN 2978)

NHSSC: 38

Alert:

• Drager has issued a Field Safety Notice regarding the slow increase of CO2-curve when using of the sampling port of Draeger Filter/HME for the products affected.
• The supplier has become aware of cases in which users have reported a slow increase of the CO2-curve when the gas sample line of the gas measurement of a Drager anaesthesia machine is connected to the gas sampling port of the filter/HME.
• Investigations taken by the supplier has shown that the comparatively slower increase (Fig. 1, page 1 of the notice) in the CO2-curve only occurs when the gas sample line is connected to the gas sampling port of a filter/HME. Other setups, as shown in Fig. 2, page 1 of the notice, are not affected.
• If a therapeutic decision is made solely on the basis of a slowly rising CO2-curve as described (Fig. 1), unnecessary medication might lead to a serious deterioration in the state of health of certain patient groups (e.g. with pre-existing cardiac conditions).

Products Affected:

• There are 10 NHS Supply Chain products affected, please refer to the product listing for full details.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Drager advise not to make therapeutic decisions based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anaesthesia machine used.
• Complete the Reply Card and return to: C.GB@Draeger.com
• If you need any further information or support concerning this notice, please contact your local Drager Representative.

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.