Alerta De Seguridad para Trade name: Blood Line for Hemodialysis. Technical Name: Hemodialysis Equipment. ANVISA registration number: 80133950083. Risk class: II. Model affected: Arterial without catabolha. Lot / Affected Series Numbers: Lot: 03717, 07217, 07717, 08517, and 09417

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Fresenius Medical Care Ltda.; Afri Medical Company.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Guidelines: 1) Look for another supplier in the market to replace the product Blood Line without Catabolha; 2) Intensify the revision (visual inspection) during reprocessing and assembly of the blood line system from batches 03717, 07217, 07717, 08517 and 09417; and (3) As soon as the new supplier's blood lines are received and put into use, notify the company immediately so that the remaining lots can be collected in stock. The communication must contain the batch numbers, the quantities per batch and the data of the contact person for the collection to take place (name, sector and telephone number). If there is no stock of the lots mentioned above, an email must be sent to, formalizing that all units have already been used. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 02/03/2018 - Date of notification notice to Anvisa: 12/04/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    According to the company, it has not yet been possible to identify whether the cause of the notifications is due to a product quality problem or is due to the process of the notifiers ( (eg reprocessing) since event notifications received by the company are concentrated on a small number of customers.
  • Acción
    Field Action Code AC001-18 triggered under the responsibility of Fresenius Medical Care Ltda. Product pickup.