MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	541B
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the unopened device shows evidence of damage/tear in the header bag.Reason for return was confirmed.This regulatory report is being submitted as part of a retrospective review and remediation as part of a capa 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.
Event or Problem Description
Medtronic received information that prior to use of the affinity nt cardiotomy venous reservoirs (cvrs), it was reported that while separating the material to be sent to customers, it was observed that the plastic packaging where the material is found was marked and with a small tear.The second unit that was in the box was also broken.Upon inspection of the units that were being separated, all of them were noted to be torn or had holes.It was decided that all of the oxygenators in the facility would be inspected and out of the 6 batches, 4 were affected.Of the (b)(4) oxygenators, approximately 168 units were out of service.There was no patient involvement, so no adverse effect occurred.One of the cradles where the oxygenator was located was slightly damaged, but in a distant place where the packaging was broken, but the cardboard boxes, where the two oxygenator units can be seen, were all intact.The vast majority of these boxes had not been opened, until authorized was given to inspect them.Medtronic received additional information that there were no devices or components missing or wrong in the package.The products were not used.

• Brand Name: AFFINITY NT
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24151729
• Report Number: 2184009-2026-00150
• Device Sequence Number: 15695504
• Product Code: DTZ
• UDI-Device Identifier: 00763000187842
• UDI-Public: (01)00763000187842(17)241129(10)225545333
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K241352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2024
• Device Model Number: 541B
• Device Catalogue Number: 541B
• Device Lot Number: 225545333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown