Alerta De Seguridad para Business Name: Heartware - Ventricular Assist System. Technical Name: Intracardiac Pump. ANVISA registration number: 10339190685. Risk Class: IV. Affected Model: All components that are part of the Heartware Ventricular Assist System. Serial numbers affected: bat013046; bat013114; BAT013820; BAT013825; BAT014350; BAT014351; BAT014352; BAT014353; BAT015058; BAT015059; BAT015060; BAT015061; BAT015062; BAT015065; BAT015066; BAT015070; BAT030136; BAT030210; BAT030245; BAT030247; BAT091007; BAT091113; BAT091133; BAT091137; BAT091139; BAT092750; BAT092755; BAT092781; BAT092793; BAT092795; BAT092802; BAT092807; BAT200397; BAT200399; BAT200479; BAT200484; BAT200488; BAT200519; BAT200550; BAT200552; BAT200621; BAT200678; BAT200720; BAT200771; BAT200772.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medtronic Comercial Ltda; HeartWare, Inc.

¿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
    The company makes the following recommendations for managing the power supply of the HVAD Systems in the Customer Charter: • Reinforce the importance of always ensuring that TWO power sources (AC or DC adapter plus one battery OR two batteries) are connected to the entire (except when changing the power source). Reinforce best practice guidelines for managing power supplies when you sleep and wake up: - Go to sleep, connect a fully charged battery, and then plug in the AC adapter. - When getting up in the morning, be sure to connect two fully charged batteries. Instruct patients to report persistent and unexpected audible sounds to the VAD team for additional instructions. Refer to Appendix A of the Customer Charter: HVAD System with Controller 1.0 - Identifying Behaviors of Unexpected Power Source Change. Refer to Appendix B: HVAD System with Controller 2.0 - Identifying Behaviors of Unexpected Power Source Change. Report any unexpected events to your local Medtronic representative and file a complaint, including records of the normal processes. If unexpected behavior persists and is responsible for possible confusion or anxiety of the patient, consider instead replacing the suspected source of energy and returning it to Medtronic for analysis during the complaint handling process. If unexpected behavior continues after replacement of the suspected energy source, consider replacing the Controller - if the condition of the patient allows according to the clinical judgment. Refer to the HVAD System Instructions for Use for detailed guidelines on controller replacement performance. 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: 01/05/2018 - Date of notification notice to Anvisa: 05/08/2018 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
    The company informs about the possible transient interruption of the electrical connection of the power source of the hvad controller (battery, ac adapter or dc adapter) to the hvad controller that may result in an alteration of energy not intended for the secondary power supply and / or audible sounds unexpected ("beeps"). this interruption, which may occur while the power source remains physically connected, is due to the oxidation of the connection surfaces between a power supply connector and the power supply socket on the controller and usually lasts between 1 and 2 seconds. further, the company informs that unexpected beep may occur when the interruption resolves automatically and may cause confusion to the patient or caregiver, since the controller may show sufficient battery capacity or ac / dc connectivity at the time of audible sound. a critical battery alarm can also be briefly displayed due to this phenomenon.
  • Acción
    Field Action Code FA817 under the responsibility of the company Medtronic Comercial Ltda. Communication to customers who purchased the product, describing the problem, how to identify it, how to use it, and how to report the problem. Upon being contacted by ANVISA, the company informed that it is developing a definitive solution to the problem, which will be announced as soon as it is finalized.


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source