Safety Alert for Trade Name: Intra-Aortic Balloon Pump. . Technical Name: Intra-Aortic Balloon Pump System. . ANVISA registration number: 10390690062.. Risk Class: III. . Model affected: CARDIOSAVE. . Serial numbers affected: CH207880C5; CH245699K6

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.

Patients receiving therapy with BBIA are in critical condition. Failure to start or stop suddenly may result in unsafe hemodynamic instability. Until the top protective cover is installed by the company, follow the instructions below when using the Cardiosave intra-aortic balloon pump: 1) According to the Care section of the BBIA Cardiosave Operating Instructions, "Never place fluids on the top of this unit. Make sure that the vessel and the saline tubing are not hung directly on the BBIA. In the event of an accidental spill, immediately clean and inspect the unit to make sure there are no risks. "2) In an unusual event in which a sudden interruption of therapy occurs, transfer the patient to an alternative BBIA. The Instructions for Use of the Intra-Aortic Balloon Catheter (BIA), reiterates that the catheter should not remain inactive for more than 30 minutes due to the potential formation of thrombi. If an alternative BBIA is unavailable, inflate the BIA manually with air or helium and aspirate immediately, repeat every 5 minutes until BBIA is available, or alternatively the intra-aortic balloon catheter should be removed from the patient. Check the instructions for use of the intra-aortic balloon catheter, and inflate and manually disinfect the catheter. The patient should be treated according to the treatment protocols of his unit and the clinical criteria of the caregivers to ensure hemodynamic stability. 3) 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 (http: // portal .anvisa.gov.br / 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: 04/05/2018 - Date of notification notice to Anvisa: 05/15/2018 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. (...)