AFFINITY NT BALANCE

Description of Event or Problem

Medtronic received information that at an unspecified time, this Affinity NT Oxygenator and Affinity NT cardiotomy Venous Reservoir had an issue that resulted in the significant increase of the FIO2, so that during cardiopulmonary bypass the device can obtain an acceptable PO2 range of between 100 - 200. Customer believes it could be a membrane issue with the batch. Use of device was unspecified. There was no patient impact reported with this event.

Additional Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation as part of a CAPA (#726178) action. Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.