Patient information were not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the arterial cannula.The incident occurred in (b)(6).Per exemption number e2016005, sorin group (b)(4) is submitting the report for both sorin group (b)(4) (manufacturer) and livanova usa., inc.(b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
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Sorin group italia manufactures the arterial cannula.The incident occurred in (b)(6).The complained cannula was not made available for investigation.However, the customer has returned 6 units of the same batch of the complained unit (lot 1806200027).In order to better investigate the issue, additional 6 units assembling the same batch of cap of the complained cannula were pulled from livanova stock.Each of the 12 cannula devices were subjected to visual inspection and functional test.Visual inspection did not identify any issue: the caps resulted correctly assembled to the connectors and the caps resulted all conforming to specifications (in detail the presence and the patency of the hole in the cap was confirmed for all caps).Functional test confirmed the devices behave as expected.According to livanova investigation all units resulted correctly assembled and behaved as expected.Ifus of the cannula recommend verifying the patency of the cap and to ensure that the caps are securely tightened before the use of the product.Having no possibility to investigate the complained device, it could not be ruled out that the disconnected cap was related to incorrect assembly.As part of the continuous improvement project, to prevent further reoccurrences, the work instructions to assemble the cap has been updated inserting recommendation and photographic evidence.As the frequency of this type of event is low (improbable), no other action will be undertaken.H3 other text : device not available.
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