Field Safety Notice Intersurgical Various Clear-Therm™ Mini HMEF (ICN 3089)

NHSSC: 69

Alert:

• Intersurgical has issued a Field Safety Notice following reports that the two housings of some HMEF devices have been found to separate when a force is applied during handling of these products or movement and torsion due to repositioning of the patient.
• Clear-Therm Mini HMEF is intended for reducing the risk of bacterial and viral contamination of patients, medical devices, and equipment, whilst also reducing moisture and heat loss from the patient’s respiratory gases within anaesthesia, critical and respiratory care breathing systems.
• The reported separation of the HMEF would cause gross leakage from the device, which in turn would result in leakage of gas from the breathing system.
• This could have the effect of the patient not receiving the prescribed mixture of anaesthetic gas and/or the prescribed ventilation, reducing the FiO2 of inspired gases and resulting in the patient becoming hypoxic.
• Intersurgical advise their investigation and inspection of potentially affected stock has the estimated probability of failure rate to be unlikely, which equals to 0.01% to 0.001% (1 in 10,000 to 1 in 100,000 products).

Products Affected:

• Two of the products affected are available via NHS Supply Chain:

• Please note only the lot numbers quoted in the Field Safety Notice, are affected.
• Intersurgical confirm this is not a product removal due to the current limited availability and to allow continuity of supply of the Clear-Therm™ Mini HMEF devices.
• Intersurgical confirm corrective actions have been implemented to the manufacturing process in April 2025 to eliminate this problem for current and future supply.
• Please be aware that some residue stock of the affected lots remains in the supply chain.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• To ensure the safety of patients Intersurgical recommend the following actions are taken in addition to those detailed in the Instructions for Use (IFU) provided with the device:
  • Identify any potentially impacted products from the affected codes and lot numbers listed in the Field Safety Notice
  • Immediately before use unpack the device and carry out the check as described in the Field Safety Notice
  • All users must check the HMEF housing is securely welded by holding both connection tapers at each end and apply a downward breaking force by flexing the tapers in the direction shown by the arrows, see page 4 of the Field Safety Notice.
• Complete and return the Reply Form provided to priority@intersurgical.co.uk, to confirm receipt of this notice and that the necessary actions are being taken.
• Where you have tested the devices and found the weld to be unsatisfactory, please raise a product complaint.
• See our Useful Links section to access our product complaint form.

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.