Livanova received a report stating that connection between the revolution disposable pump and the inlet of the oxygenator disconnected during the procedure.The involved parts (oxygenator, tubing and pumps) were not made available for return.According to follow up information with the customer, the connection that disconnected as not tie-wrapped, as recommended in the product instruction for use.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.Based on all the gathered information, the most likely root cause of the reported tubing disconnection was an alteration of the chemical / mechanical characteristics of the tubings (which are supplied by a supplier).The supplier was formally notified.The risk is acceptable.No other action will be undertaken.Livanova will keep monitoring the market.H3 other text: device not available.
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