INOmax (nitric oxide) - Difficulties in closing the cylinder valves after use: precautions for use when disconnecting the cylinders from pressure regulators.

Summary

• There have been reports of users not being able to properly close the INOmax® cylinder after opening, when the cylinder is not yet empty (as indicated by the pressure still showing on the regulator).
• The estimated defect ratio is 0,17 % of cylinders delivered. The malfunction does not affect the delivery of INOmax to the patient during treatment. Despite the inconvenience to the users, no recall is performed because of risk of shortage of a patient critical medicinal product.
• If this occurs, the user may not be able to purge the pressure regulator hose according to the instructions in the user manual, in order to remove the pressure regulator from the cylinder valve. The wash out of NO2 is not impacted.
• Correct administration of INOmax® is not affected by the reported malfunction. No adverse effects in patients treated with malfunctioning INOmax cylinders have been reported.
• If such a malfunction occurs, follow the steps outlined below:
  • Do not interrupt a treatment in progress and continue to use the cylinder until the end of the treatment or until the cylinder is empty (empty cylinders can be closed without any problems).
  • If this should occur when starting therapy, it is recommended to switch to the back-up administration system if possible. If it is not possible to switch to a back-up system you can still start and run the therapy using the cylinder that cannot be properly closed.  
  • Never try to remove the pressure regulator from the valve forcibly or use any tools/such as a screwdriver to pry off the regulator as cold burns might occur through contact with the pressure regulator equipment during attempts to disconnect it from the cylinder while the connection is still under pressure.
  • Try to close the INOmax cylinder valve via the INOmeter by applying firm pressure with your hand.
  • If this does not help to close the cylinder valve, contact your Linde representative for further support.
  • Use a back-up administration system as necessary.