The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a medical device safety alert concerning Hemolung Cartridge (a component of the Hemolung Cartridge Kit, reference number 10000) manufactured by ALung Technologies Inc.
ALung has identified a manufacturing defect in a limited number of Hemolung Cartridges which may result in unexpected failure of the device and cessation of therapy. The root cause has been determined to be inadequate coverage of adhesive on the 'bearing cap' glue joint. The glue joint which is located inside the rotating core within the Hemolung Cartridge, may fail due to inadequate bond strength.
The manufacturer further explains that when the glue joint fails, the core becomes unsecure and is pulled by the force of the magnetic coupling, until it comes in contact with the bottom plate of the Hemolung Cartridge. Once contact is made, the core ceases to rotate and a higher than normal motor current is generated, causing the Hemolung Controller motor fuse to open, stopping therapy and alarming to alert the user. The Hemolung Controller cannot be used following the failure due to the blown fuse, and services will be required.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON350666
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 18 December 2013