Events

Alerta De Seguridad para AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines

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

¿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
    2015-02-06
  • Fecha de publicación del evento
    2015-02-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150206a.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: gambro ak 200 s and ak 200 ultra s nocturnal home hemodialysis machines australian therapeutic goods administration (tga) posted a medical device safety alert concerning ak 200 s and ak 200 ultra s nocturnal home hemodialysis machines, manufactured by gambro. the manufacturer has received complaints related to a technical error in the ak 200s nocturnal home haemodialysis machines, which will stop all the pumps and close the venous clamp. this has led to 3 cases of 400ml of blood loss and a 2 day treatment delay. a further 21 reported cases resulted in a technical error and a minor treatment delay. one section in the operator’s manuals for the ak 200 s and the ak 200 ultra s instructs the user to contact technical service and to restart the blood pump to return the extracorporeal blood to the patient. restarting the blood pump is however not possible, since the venous clamp is closed and the consequence will be a blood loss according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00093-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 february 2015.

Device

AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Gambro AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines
  • Manufacturer
    Gambro

Manufacturer

Gambro