As part of its ongoing quality monitoring and review processes Ikaria has found out this failure. All Inomax DS systems in Canada also are being voluntarily recalled.
Ikaria said that a component within the pressure switch, which monitors for when the drug supply should be replaced, may tear due to which the flow of Inomax to the patient is not immediately interrupted. While the patient is not immediately impacted by the pressure leak, subsequent risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a replacement system.
Ikaria also stated that this interruption or delay in the administration of Inomax therapy may lead to worsening of systemic oxygenation indices (such as hypoxemia, especially manifested as decreased arterial oxygenation saturation), hypotension, and/or increase in pulmonary arterial pressure.
Ikaria has cautioned the clinicians that if a leak is suspected they should not interrupt the delivery of Inomax, rather, they should verify an adequate amount of Inomax remains in the cylinder, switch to the manual back-up system using the INOblender by connecting the Inomax Inlet Hose of the INOblender directly to the Inomax regulator, and follow the standard procedure for use of the INOblender as the primary back-up method for manual ventilation.
Daniel Tasse, chairman and CEO of Ikaria, said: “We are working very closely with our customers to complete a timely and orderly replacement of the affected Inomax DS systems.”
