The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a medical device safety alert concerning Femoral Arterial and Venous Cannula manufactured by Edwards Lifesciences Corporation.

The manufacturer has identified an increase in the use of Femoral Arterial and Venous Cannula in adult and pediatric populations in a manner that is not intended resulting in leaks. Some of the reported events resulted in death and others in significant blood loss. The information received is from cases where the product was in use during an Extracorporeal Membrane Oxygenation (ECMO) procedure. Additionally, some of the reported events involved device placement outside of the indicated femoral locations resulting in dislodgement of the product and significant blood loss.

As a result, the manufacturer is adding contraindications to the instruction for use included with the affected models:

• Femoral Access Cannulae are contraindicated for long-term use (> 6 hours), including Extra Corporeal Membrane Oxygenation (ECMO) procedures.
• Devices are contraindicated for placement in vasculature outside of the femoral artery or vein.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON355530

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 31 December 2013