Field Safety Notice Intersurgical IPPB Flextube™ Breathing System (ICN 2671)

MHRA TBC

NHSSC: 46

Alert:

• Intersurgical has issued a Field Safety Notice following a report of a loose connection between the nebuliser and supply line T-piece IPPB Flextube™ breathing system.
• IPPB breathing systems are for short term use with spontaneously breathing patients for the purpose of assisting lung expansion and delivering medication in a hospital environment.
• When the system is pressurised, there is the possibility for the T-piece to detach from the nebuliser.
• The disconnection of the nebuliser/ exhalation valve control T-piece during use could cause a minor delay or interruption of treatment.
• Intersurgical advise only one report has been received, with the problem identified before use on the patient.

Products Affected:

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

• The affected Lot numbers are listed on page 1 section 7 of the Field Safety Notice.
• Intersurgical advise they have implemented corrective measures in the manufacturing process to eliminate the problem and taken the opportunity to improve the current Instruction for Use provided with these products.
• The Pre-Use Checks section will in future also include with the following warning:
  • “WARNING: Every component of the breathing system must be visually inspected and checked for function, leakage, and occlusions, immediately before use on each patient. Ensure that connections are secure using a push and twist action.”

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
• Please note Intersurgical advise this is not a product recall, there is no need to withdraw or return 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.