Events

Alerta De Seguridad para BAXTER LONG PERMANENCE TWIST-CLAMP 6 TRANSFER EQUIPMENT, Hazard Class II, Brand: Baxter, Record: 10068390005, code 5C4482, all existing batches.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Hospitalar Ltda.; Baxter Healthcare Corporation.

¿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
  • ID del evento
    1728
  • Fecha
    2015-10-30
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    According to the manufacturer's information, the risk of improper use of transfer equipment for peritoneal dialysis may result in contamination. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Identified absence of information on product label.
  • Acción
    Update of the instructions for use. The recommendation will be included on the label to monitor the function of the thyroid in nursing or child patients, as there is the remote risk of change. The need to use aseptic technique in order to avoid contamination leading to infection or peritonitis will be reinforced. Changes to the instructions for use include: • This equipment should be used with the Baxter Titanium Adapter for the peritoneal dialysis catheter for disconnection and for connections to the Homechoice cycler where aseptic connections and disconnections are made at the junction of the extension of the catheter; //// • For connection and exchange of the Equipment, the Transfer Team Exchange technique provided by the Baxter Clinic Team must be followed. ///// It is recommended that thyroid function be monitored in patients with small volumes of peritoneal dialysate filling, typically infants or children; //// Reprocessing or reusing single use equipment can lead to contamination and impairment of the function or structural integrity of the equipment; /// Do not use if the guards are not in place; //// This product does not contain natural rubber latex. ////////// Baxter requests that patients be advised by clinics and hospitals about these changes that will be made in the instructions for use and that the importance of following the instructions for use of the products is emphasized. (SEE LETTER TO THE CLIENT). Action code: FCA2013-013

Device

BAXTER LONG PERMANENCE TWIST-CLAMP 6 TRANSFER EQUIPMENT, Hazard Class II, Brand: Baxter, Record: ...

Manufacturer

Baxter Hospitalar Ltda.; Baxter Healthcare Corporation