Alerta De Seguridad para Trade name: Atrial catheter. Technical Name: Catheters. ANVISA registration number: 10166360031. Risk class: IV. Model affected: AC, AE, AH. Serial number affected :. Code AC: lot 06 series 01 to 10, lot 07 series 01 to 10. Code AE: lots 17 to 29 series 01 to 10. Code AH: lot 04 series 01 to 10

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por HP Bioproteses 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
  • 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
    There are no additional recommendations as it is recommended in the Instructions for Use that patients are permanently monitored for the presence of signs and symptoms of system failure and already describes the risk of catheter fracture and migration to the right atrium. 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: 08/02/2018 - Date of notification notice to Anvisa: 02/16/2018 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
    The manufacturer received two reports of adverse events occurring with model ah, batch / series 14-01 and 22-01. the report describes that after a few months after implantation, patients returned with symptoms indicating failure of the cerebrospinal fluid drainage system. an imaging examination revealed that the atrial catheter had ruptured, requiring replacement. patients were well, and the catheter was replaced. the product has been marketed for more than 20 years (initially with the registration 10166360006), without any occurrence. both incidents occurred in the same hospital, which may indicate a failure in handling. despite the suspected failure to handle, the manufacturer chose to collect the product and study changes in order to reduce the risk of disruption even in cases of improper handling.
  • Acción
    Field Action Code RA 518 triggered under the responsibility of HP Bioproteses Ltda. It will make recollection.