Alerta De Seguridad para Trade name: HEMOSIL PLASMA DEFICIENT IN FACTOR XII 10 X 1 mL - 10 x 1 mL. Technical Name: Deficient Lasma in Coagulation Factors. ANVISA registration number: 80003610279. Risk class: II. Model Affected: N / A. Serial numbers affected: N958653 (06 units), N261273 (42 units)

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

¿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
    2342
  • Fecha
    2017-07-24
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    Comply with the guidelines indicated on the product label on 2 hour onboard stability. And also follow the guidelines sent through alert. 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 - Date of identification of the problem by the company: 06/28/2017 - Date of notification notice to Anvisa: 24/072017 The company that owns the affected product is responsible for contacting its customers in a timely manner 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 stop shipment document h2017-015 sent by the manufacturer on 06/28/2017, during the stability factor test on board the acl top (equipment), hemosil factor xii deficient plasma failed to meet the criteria of 24 hours. after stability testing, the onboard stability period of the related lots was changed to 2 hours. on 12/07/2017 was sent an instruction and labels for the identification of the product with the new term stability on board. forms for inspection, control and registration of labeling implementation were also reissued.
  • Acción
    Field Action Code H2017-015 triggered under the responsibility of the company Werfen Medical Ltda. Will update product label and customer communication.

Manufacturer