FDA MedWatch - VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage

VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage

AUDIENCE: Emergency Medicine, Risk Manager, Patient

ISSUE: Dräger discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This can lead to serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.

This issue pertains only to the VentStar Oxylog 3000 Disposable Pediatric Patient Circuit. There is no issue or problem with the Oxylog 3000/3000 plus ventilator.

BACKGROUND: The VentStar Oxylog 3000 disposable pediatric patient breathing circuit is used with the Dräger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators for pediatric patients who require ventilation.

RECOMMENDATION: On May 31, 2016, the firm notified consignees of the problem via an Urgent Medical Device Recall letter. The letter directed consignees to identify and dispose of the affected products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the Medwatch safety alert, including a link to the FDA Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm515152.htm