During follow-up communication with the customer, it was confirmed that there was no patient impact as a result of this event.The customer also stated that the livanova perfusion tubing set and the pump used during the procedure are not suspected to be the cause of the issue.No further information has been provided.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by customer.
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No specific components of the perfusion tubing set were mentioned by the customer or otherwise implied to have contributed to the event.No photos of a potential defect were provided by the customer, and no product was returned to livanova in connection with this report.In addition, the customer has stated that they do not believe that the tubing set was the source or cause of the air in the line.No further investigation is possible at this time.No root cause or corrective actions were identified, as there was no information provided to conclusively suggest a failure occurred.
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In the first follow-up report, submitted september 14, 2018, the "date of this report" field was erroneously entered as september 10, 2018.This should have been entered as the submission date; september 14, 2018.In the first follow-up report, submitted september 14, 2018, the "if follow-up, what type" field was erroneously left blank.This field should have been filled in as "additional information.".
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