It was reported that the customer received hls set with punctured packaging.No harm to any person reported.The affected product was technically investigated at the getinge laboratory of the manufacturer on 2021-01-27.Hereby a hole was detected within tyvek cover of the hls intellipack 1.The sealing of the tyvek cover was still intact.After opening of the intellipack, it could be seen that the velcro straps (used for fixating hls module) were a bit loose.At the bottom of the intellipack one velcostrap was not fixated with adhesive tape which allows the velcostrap to slip and this led to a less fixated hls module.The weld points of the welded inlay of the intellipack 1 were still intact.The most probable cause of the reported failure "punctured packaging" was determined to be an inadequate fixation of the hls module onto the insert of the intellipack due to a missing adhesive tape.This led to vertical movement of the hls module during transport whereby the brackets of the venous measurement cell holder at the blood inlet connector pierced the sterile tyvek cover of the intellipack 1.Thus the reported failure "punctured hls set cover" could be confirmed.As a preventive action mcp production was informed about the investigation results and a retraining of the affected process was performed.The production records of the affected hls set (batch 3000179556 ) were reviewed on 2022-02-10.Following steps are performed according to the bop with a 100 % inspection: -welding of inlay with intellipack 1; -adding cohesive tape; -final check.According to the final test results, the hls module with serial number (b)(6) passed the tests as per specifications.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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