Alerta De Seguridad para Commercial Name: Prismaflex Monitor. Technical Name: Prismaflex Control Unit. ANVISA registration number: 80145240438. Risk Class: III. Affected Model: 955052, 114489, 107493 and 113082. Serial numbers affected: See Attached List, Attachment 1

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; Gambro Industries.

¿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
    Users / patients and distributors should take the following actions: 1. Operators may continue to use the Prismaflex control units that have not displayed the "Out of Range Voltage" malfunction alarm. 2. According to the company, a technical representative will go to your institution to determine the corrective plan and schedule the firmware update. 3. If you purchased this product directly from Baxter, complete the attached customer response form and return it to Baxter via e-mail to or fax to (XX) 11 5635-0106 or 0800 012 5522 , even if there is no remaining stock at your facility. Prompt return of the customer response form will confirm receipt of this notification and will prevent you from receiving this notice several times. 4. If you distribute this product to other institutions or departments within your institution, please send a copy of this document to them. 5. If you are a reseller, wholesaler, distributor or original equipment manufacturer (OEM) distributing any affected product to other institutions, please notify your customers about this Urgent Medical Device Correction in accordance with the usual procedures. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa / notivisa). 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 Complementary Information: - Date of identification of the problem by the company: 03/03/2018 - Date of notification notice to Anvisa: 05/23/2018 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
    Possibility of failure of the device with the electronic components of the pump module. failure mode may result in an "out of range voltage" malfunction alarm, which causes the device to enter a "safe state" and does not function until service is performed. baxter is working on a firmware to correct the problem.
  • Acción
    Field Action Code FA-2018-014 under the responsibility of the company Baxter Hospitalar. Field Correction.