Events

Safety Alert for Hemolung Cartridge

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by ALung Technologies Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-12-18
  • Event Date Posted
    2013-12-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131218.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: alung technologies hemolung cartridge 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.

Device

Hemolung Cartridge
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ALung Technologies Hemolung Cartridge
  • Manufacturer
    ALung Technologies Inc

Manufacturer

ALung Technologies Inc