Consumer Lawyers

Jan 8, 2012: FDA Recall of Ikiaria INOMax DS

In Uncategorized on January 8, 2012 at 2:25 pm

The FDA has issued a Class 1 recall of the Ikaria INOmax DS Drug Delivery System.

The recalled drug delivery system is used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients.

Healthcare professionals were told to stop using the product after the FDA discovered corrosion at its electrical contacts could cause erratic readings of nitric oxide monitors. The consequences of the defect include inadequate oxygen reaching the tissues in the body, low blood pressure, a slowed heart rate, cardiac arrest, organ damage, acute respiratory distress syndrome, and neurological deficits. In more serious cases, the defect can lead to death.

From the FDA site: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm285803.htm?source=govdelivery

ISSUE: FDA notified healthcare professionals of a Class I recall of Ikaria INOmax DS Drug Delivery System. Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals. Adverse consequences may include inadequate oxygen reaching the tissues in the body (hypoxia), low blood pressure (hypotension), slower than normal heart rate (bradycardia), cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

Affected serial numbers include DS20070005-DS20100865. This product was manufactured from March 12, 2007 through February 2, 2011 and distributed from September 4, 2007 through February 2, 2011.

BACKGROUND: INOmax DS Delivery System is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients.

RECOMMENDATION: Ikaria implemented a service process change involving the application of DeoxIT, an anti-corrosion lubricant specifically created to prevent fretting corrosion. DeoxIT was added to the preventive maintenance plan for all INOmax DS Drug Delivery Systems and was performed when the Systems rotated through Ikaria’s Regional Service Centers for any routine service activity.

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