MAUDE Adverse Event Report: PERFUSION SYSTEMS OXY/CVR COMBO BB841 FUSION W/BALANCE 26L; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	BB841
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of a fusion oxygenator and cardiotomy venous reservoir (cvr) , it was reported that during the preparation for extracorporeal circulation surgery in the operating room, an integrated membrane oxygenator was selected to use.The sterile packaging of the product was found ruptured and damaged after opening the package, so it was immediately replaced with another oxygenator.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that there was no missing, wrong devices or components in the package?.
Additional Manufacturer Narrative
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.

• Brand Name: OXY/CVR COMBO BB841 FUSION W/BALANCE 26L
• 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: 24052065
• Report Number: 2184009-2026-00046
• Device Sequence Number: 9856335
• Product Code: DTZ
• UDI-Device Identifier: 00643169354869
• UDI-Public: (01)00643169354869(17)251030(10)227640509
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K240666
• 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): 01/13/2026

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
• Device Expiration Date: 10/30/2025
• Device Model Number: BB841
• Device Catalogue Number: BB841
• Device Lot Number: 227640509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 10/30/2023
• 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