Events

Alerta De Seguridad para Hemolung Cartridge

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por ALung Technologies Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-12-18
  • Fecha de publicación del evento
    2013-12-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131218.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: ALung Technologies Hemolung Cartridge
  • Manufacturer
    ALung Technologies Inc

Manufacturer

ALung Technologies Inc