Pediatric Patient Breathing Circuit Recall Issued Due to Risk of Valve Leaks

A recall has been issued for an attachment used with pediatric ventilators, due to a risk that it may be defective and place children at risk of carbon dioxide poisoning, acidosis or death.

The FDA announced a Dräger VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Class I recall on August 1, indicating that a faulty valve that may cause patients to breathe exhaled gas, potentially causing serious and life-threatening health problems.

The pediatric breathing circuit recall was issued because a check valve may leak. A leak in the valve can result in a patient rebreathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels.

This is a very serious problem that may also lead to adverse health side effects, including excessive carbon dioxide in the bloodstream and increased acidity in the blood, which can lead to death.

The Dräger Oxylog 3000 and Oxylog 3000 Plus Emergency Transport Ventilators are for pediatric patients who require ventilation. Doctors, nurses and emergency technicians are the primary operators of the products used on patients during transport, in emergency departments or in the recovery room.

The recall affects 1,530 VentStar Oxylog 3000 Disposable Pediatric Patient Circuits in the U.S. with catalog number 5704964. The units were manufactured between May 2013 to March 2016 and were distributed between May 2013 to March 2016. The FDA noted there was no recall or problems with the Oxylog 3000/3000 Plus Ventilator itself.

A Class I recall is the most serious type of recall. A Class I recall is only issued when the FDA has reason to believe that the use of the product or drug will cause serious harm or serious side effects, including death, to the user.

Dräger notified affected customers of the problem on May 31, 2016, via an Urgent Medical Device Recall letter. The letter called on customers to identify and dispose of the affected products.

Healthcare professional and patients should report adverse events or side effects related to the use of VentStar Oxylog 300 to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.