Safety Alert for Intra-Aortic Balloon Pump System Name: Intra-Aortic Balloon Pump Number: 10390690062 Risk Class: III Affected Model: Intra-Aortic Balloon Pump CS100; Intra-aortic balloon pump CS300 Affected serial numbers: All units distributed between March 24, 2003 and June 16, 2017

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 BCIA therapy are critically ill and sudden cessation of therapy may result in hemodynamic and unsafe instability. Follow the instructions below when using an affected BCIA CS100 / CS100i or CS300: 1) According to the WARNINGS section of our BCIA CS100 / CS100i or CS300 Operating Instructions / User, clinicians are instructed not to leave the patient unattended. during BTI therapy. 2) An additional risk 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 BCIA CS100 / CS100i or CS300 Operating Instructions: WARNING: The patient flask must not remain inactive on the patient (ie, not inflate or deflate) for more than 30 minutes due to the possibility of thrombus formation. In the unlikely event of interruption of therapy, transfer the patient to an alternate BCIA. Intra-Aortic Balloon Catheter (BIA) Instructions for Use reiterate that a catheter should not remain inactive for more than 30 minutes because of its potential for thrombus formation. If an alternative BCIA is not available; inflate the BIA manually with air or helium gas and aspirate immediately, repeat every 5 minutes until an alternate BCIA is available or alternatively the BIA catheter should be withdrawn from the patient. Consult the instructions for use of the intra-aortic balloon catheter by manually inflating and deflating a 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) For Blood Detection Alarm - Until service is performed, we recommend following the Blood Detection Help Screen found in the operating instruction to validate or eliminate alarms. We also recommend that you review the water condensation procedure (Operating Instructions CS100 / CS100i and CS300, section 3.4.1) to reduce the potential for condensate build-up. If the BCIA fails to complete and properly cancel the alarm, remove the service BCIA and contact your local Maquet / Getinge Sales and Service Office. 4) For Fluid Inlet - Until service is performed, we recommend a revision of the CS100 / CS100i and CS300 Operating Instructions with regard to fluid placement and fluid bag suspension precautions on the BCIA. "Never place fluids on the top of the unit. Make sure that the saline container and tubes are not hanging directly on the BCIA. In case of accidental spillage, immediately wipe and perform maintenance on the unit to ensure that there are no hazards. "Additional information: - Date of identification of the problem by the company: 07/17/2017 - Date of notification notice for Anvisa: 06 / 09/2017 The company that owns the affected product is responsible for timely contacting its customers in order to ensure the effectiveness of the ongoing Field Action. 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.