Events

Notificaciones De Seguridad De Campo acerca de HomeChoice APD System, HomeChoice PRO System

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por BAXTER HEALTHCARE CORPORATION.

¿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
  • Fecha de publicación del evento
    2014-05-05
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2014/05/05/azno-obavestenje-o-medicinskim-sredstvima/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has given a notice accompanying the instruction manual for the "homechoice / homechoice pro" system, which provides specific instructions for patients if there is a suspected increased intraperitoneal volume ("iipv"), also known as "overfill". specifically, "iipv" is an inherent risk of peritoneal dialysis therapy. the condition is characterized by an unintended excess fluid in the peritoneal cavity that may become symptomatic, especially in high-risk population groups (infants, infants, young children and all patients with significant cardiac or pulmonary diseases). dialysate overfill (iipv) or insufficient dialysate leakage during "pd" therapy may lead to excess fluid in the abdomen of the patient followed by appropriate specific symptoms.

Device

HomeChoice APD System, HomeChoice PRO System

Manufacturer

BAXTER HEALTHCARE CORPORATION