INOmax (nitric oxide) cylinders: valve defect might stop gas delivery early in some cylinders

While this defect is still being investigated, we remind you to always have a full spare cylinder loaded on the delivery device so the cylinders can be switched without delay.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 12 February 2015
• Last updated: 16 February 2015 — See all updates

• Therapeutic area: Anaesthesia and intensive care, Cardiovascular disease and lipidology and Paediatrics and neonatology

When using nitric oxide cylinders, we remind you:

• to always have a full spare cylinder loaded on the delivery device so the cylinders can be switched without delay
• to always deliver INOmax using devices with pressure sensor monitors and gas monitor alarms - the low pressure alarm will sound if the valve closes
• that devices without low pressure alarms are not safe to use
• purge the regulator of the second cylinder when switching cylinders, before connecting it to the delivery device –this prevents excess NO₂ formation
• to take extra care during patient transfer - always have back-up cylinders available, even for a short transfer
• report any suspected defective cylinder valves on a Yellow Card: www.gov.uk/yellowcard

A defect has been reported and this might cause the valves in some INOmax (nitric oxide) cylinders to close while in use, before the cylinder is empty. This abruptly stops gas delivery earlier than expected. Unless the cylinder is changed immediately, the following life-threatening rebound effects can occur:

• increase in pulmonary artery pressure
• decrease in oxygen saturation
• cardiovascular collapse

This applies to 400 ppm and 800 ppm cylinders of 2 L and 10 L capacity. It is not possible to identify defective cylinder valves in the hospital setting.

The licence-holder is investigating an incident that might be linked to this valve defect (the patient did not experience any adverse events related to this incident) and the cause of the defect.

Switching to alternative products

Nitric oxide products other than INOmax are available but may have different concentrations of nitric oxide and different cylinder fill pressures. Also, it may be necessary to change the hardware or software of the nitric oxide delivery system when switching between products. If you switch from INOmax to another nitric oxide product, ensure that:

• the delivery system is compatible with the new nitric oxide product
• staff are trained with the new product and familiar with any new connections and dosing schedules

Licensed indication

Nitric oxide, in conjunction with ventilatory support and other appropriate active substances, is licensed:

• for the treatment of newborn infants ≥ 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation
• as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation

Further information

Letter sent to healthcare professionals in December 2014

Article citation: Drug Safety Update volume 8 issue 7, February 2015: 2

Published 12 February 2015
Last updated 16 February 2015 + show all updates

1. 16 February 2015

   Published to website

2. 12 February 2015

   First published.