Events

Notificaciones De Seguridad De Campo acerca de Hemodialysis Conventional Product

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Baxter International, Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Baxter healthcare corporation issues a voluntary recall of the hemodialysis conventional product line with the above product codes and batch numbers due to customer complaints regarding fracture of the pre-dialysis artery expansion chamber at various stages of treatment. following an investigation, baxter found that there had been a change in the formulation of the material which could have led to increased material fragility and reduced impact resistance.

Device

Hemodialysis Conventional Product
  • Modelo / Serial
    114525 BL105 1701 to 1719 between 31.12.2019 and 04/30/2020 114526 BL121P 1701 to 1719 between 31.12.2019 and 04/30/2020 114527 BL130PSN 1701 to 1719 between 31.12.2019 and 04/30/2020 114557 BL208BD 1701 to 1719 between 31.12.2019 and 04/30/2020 114559 BL224BD 1701 to 1719 between 31.12.2019 and 04/30/2020
  • Manufacturer
    Baxter International, Inc.

Manufacturer

Baxter International, Inc.