There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and he found that the device was working as per specifications.Nonetheless, as per explicit customer request, he replaced the level sensor and the level module.The investigation is in progress.In case additional information pertinent to this case will be received, it will be provided in a supplemental report.
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