Safety Alert for Commercial Name: Intra - Aortic Balloon Pump. Technical Name: Intra-Aortic Balloon Pump System. ANVISA registration number: 10390690062. Risk class: III. Affected model: CS100 intra-aortic balloon pump; Intra-aortic balloon pump CS300. Affected serial numbers: All units distributed between March 24, 2003 and December 11, 2013.

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 IABP therapy are in critical condition and sudden cessation of therapy may result in unsafe hemodynamic instability. Follow the instructions below when using an affected IABP CS100i, CS100 or CS300: 1) Under the WARNINGS section of our IABP CS100i, CS100 or CS300 Operator's Instructions, clinicians are instructed not to leave the patient unattended during therapy with IABP. 2) An additional hazard associated with a sudden withdrawal is related to the static (non-inflating or deflating) condition of the balloon during cessation of therapy. It is important to note the following WARNING in the IABP CS100i, CS100 or CS300 Operational Instruction Manual. WARNING: The patient's flask should not remain inactive in the patient (ie, not inflate or deflate) for more than 30 minutes because of the potential for thrombus formation. 3) Until service is performed, we recommend that the IABP be connected before inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to complete. If the IABP fails to successfully complete the self-test and shows the test failure code 58, remove the IABP from the service and contact your Maquet / Getinge Sales and Service Office. In the unlikely event that a sudden cessation of therapy occurs, transfer the patient to an alternative LPAI. If an alternative IABP is not available, inflate the IAB manually with air or helium and aspirate immediately. Refer to the instructions for use of the intra-aortic balloon catheter, Manually Inflating and Deflating a Catheter. The IAB Instructions for Use reiterate that a catheter should not remain inactive for more than 30 minutes because of the potential for thrombus formation. Alternatively, the intra-aortic balloon catheter should be removed from the patient. The patient should be treated according to the treatment protocols of the unit and with the clinical judgment of the care providers to ensure hemodynamic stability. 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