Events

Alerta De Seguridad para BAXTER EQUIPMENT FOR PACLITAXEL WITH AIR INPUT .. Class of Risk II. Anvisa Record: 10068390316.

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..

¿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
    862
  • Fecha
    2007-04-17
  • 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
    Baxter Hospitalar Ltda has informed that it will collect specific batches of the product PACLITAXEL EQUIPMENT WITH AIR INLET, due to complaints from users regarding leakage during use. Equipment that has leaks should be kept in a sealed and quarantined container and gloves should be used to handle the material (due to the toxic potential of Paclitaxel). Anvisa's Technovigilance Unit is following up on this case. ######## Update (23/08/2007): Baxter Ltda has notified the Anvisa Technovigilance unit (UTVIG / NUVIG / ANVISA / MS) that closed the action of collecting the product EQUIPMENT FOR PACLITAXEL WITH AIR INPUT, presenting the documentation regarding the destruction of the product. According to the company, of the 24,285 units sold, 9,592 units were collected and destroyed.
  • Causa
    Leaks occur while using the equipment. product code: amc9627. defective lots: 05i19v810, 06d12v006, 06e01v313, 06g04v003 and 06h04v319.
  • Acción
    Baxter Hospitalar Ltda, the company that markets the product in Brazil, communicated the Anvisa's Technovigilance Unit on the quality deviation of the product in question. The company informed that it has already initiated the procedure of recollection with the customers, sending letters of communication to them. UPDATED 10/08/2007: Baxter Hospitalar Ltda has notified the Anvisa Technovigilance Unit that has already terminated the action of collecting and destroying the defective batches of the product Equipment

Device

BAXTER EQUIPMENT FOR PACLITAXEL WITH AIR INPUT .. Class of Risk II. Anvisa Record: 10068390316.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA