There was no patient involvement.Unique identifier (udi) number: (b)(4).Sorin group (b)(4) manufactures the inspire 8 hollow fiber oxygenator.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).On november 7, 2016, sorin group (b)(4) was notified that the user facility had submitted a report to the local competent authority.The complained oxygenator was returned to sorin group (b)(4) for investigation.Visual inspection of the returned oxygenator confirmed the disconnection of the cardioplegic connector from the oxygenator.The disconnection was caused by excessive solvent applied by the manufacturing operator, which impaired the proper adhesion of the two components of the connector.Sorin group (b)(4) has not been informed of any other similar events related to this lot.A review of the dhr did not reveal any relevant information related to the reported issue.As the root cause was identified to be an assembly error, the manufacturing floor was formally informed and trained to sensitize the personal to this issue.The occurrence rate for this type of issue is very low.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
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