Alerta De Seguridad para HomeChoice Automated Peritoneal Dialysis system(Patient At-Home Guide)

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
    2013-04-10
  • Fecha de publicación del evento
    2013-04-10
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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 homechoice automated peritoneal dialysis system(patient at-home guide) medical device manufacturer, baxter healthcare, has issued a safety alert letter to customers to inform them of the best practice for properly managing a planned or emergency disconnect from their homechoice automated peritoneal dialysis (pd) system(product code 5c4474). the homechoice patient at-home guide (part number 071964016) describes using a flexicap or opticap for high dose therapy (optichoice therapy) or for an emergency disconnect. however, the flexicap or opticap are not available in hong kong. if patients disconnect during therapy and do not reconnect using new supplies, there may be a possible of contamination of the patient line, which may lead to peritonitis. baxter advises patients that if they need to disconnect from their therapy before it is completed, they should end the therapy and then restart the therapy using all new supplies (such as solution bags and the disposable set). according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 april 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system (Patient At-Home Guide)
  • Manufacturer

Manufacturer