Safety Alert for SARNS ASSISTED CIRCULATION SYSTEM BATTERIES - Registration 80012280010 - Models 9490 and 9491.

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.

If the Centrifuge System malfunctions during cardiopulmonary bypass, the risk to the patient ranges from insignificant to severe, and depends on: • the patient's condition; • how quickly the user responds to malfunction. If used as the arterial pump, a defect can result in: • Loss of arterial flow. The patient's resulting damage can range from a temporary and well-tolerated reduction in blood pressure to cell death, resulting in neurological dysfunction, cardiac dysfunction due to inadequate myocardial circulation, end-organ dysfunction, or death in the event of a long period of no flow; • Reflux condition. This could result in: exsanguination of the patient leading to hypovolemia; entrainment of the air at the site of the aortotomy leading to a surgical intervention to remove the air to prevent neurological or end organ damage or dysfunction. If the system is used for assisted venous drainage (an infrequent application), a defect may result in: • inadequate venous drainage. This can lead to hypoperfusion if venous drainage is insufficient to maintain adequate blood flow. Any malfunction can result in user distraction and a potential delay of the process.