The age at the time of the event provided in the initial report, submitted (b)(6) 2017, was incorrect.The correct patient age is (b)(6) years.Date of death: (b)(6) 2017.Livanova (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication with the customer, livanova (b)(4) learned that air was delivered to the patient.The facility does not offer neurosurgery so the patient was sent to another hospital where he passed.The customer does not know why air was in the brain.The only anomaly identified was the slow turning of the pump but the facility was not able to confirm if this was the cause, as the air could have come from the other side as well.The device was sequestered following the event and was returned to service following maintenance from the livanova field service representative.The speed potentiometer replaced by the service representative during the on-site visit has been returned to sorin group usa, inc for investigation.Visual inspection did not identify any abnormalities or defects.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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