Alerta De Seguridad para Business Name: Heartware-Ventricular Assist System. Technical Name: Other Cardiovascular Implants. ANVISA registration number: 80583400001. Hazard class: IV. Model Affected: No Model .. Serial Numbers Affected: BATTERY LT: 1650,1650DE - BAT000001 to BAT039999; BAT090000 to BAT099999

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.

The abnormal behaviors of the HeartWare system are: A controller switches to the second battery when the first battery has more than (>) 25% of the remaining capacity (1 indicator light). Replace the first battery and remove from service. / There is a sudden change in the charge capacity of a battery (for example, a sudden change of four lights to a light. Replace the battery with abnormal behavior and remove from service / Hear beeps and the controller quickly switches between batteries Replace the battery first with more indicator lights, then replace the battery with less lights Remove the battery with more service lights as it may be a faulty battery Any of these behaviors may indicate a defective battery and , potentially lead to a very low battery or a possible power outage. If you want to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) and technical complaints (QT) for products subject to Sanitary Surveillance should To access the System, you must register and select the Health Professional option, if it is a professional or Institution / Entity 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: 08/22/2014 - Date of notification notice to Anvisa: 12/18/2017 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. (...) "