Events

Alerta De Seguridad para 15L Cycler Drainage Bag

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

¿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
    2013-11-06
  • Fecha de publicación del evento
    2013-11-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131106a.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: baxter 15l cycler drainage bag the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning 15l cycler drainage bag manufactured by baxter healthcare. the affected product code is r5c4145p. baxter has identified an issue with the roberts clamp (large clamp on the drainage bag) that is used to close the drain tube on the 15l cycler drainage bag. the large clamp may not fully close the 15l cycler drainage bag drain tube after filling and may result in leakage from the drain tube. the manufacturer is advising users of the potential issue with the clamps and to take extra care to ensure the clamp on the drain tube is closed. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01096-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2013.

Device

15L Cycler Drainage Bag
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter 15L Cycler Drainage Bag
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare