MAUDE Adverse Event Report: MC3 INC. MC3 ECMO OXYGENATOR; OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS

Model Number	48145
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak from the water line ports was identified with the mc3 nautilus extra corporeal membrane oxygenation (ecmo) oxygenator.The same leak did not appear in multiple packs.Plasma breakthrough did not occur.Patient blood loss did not occur because of the leak.An unplanned blood transfusion was not required because of the blood loss from the leak.The device was not continued in use and was replaced to complete the case.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of physical damage or abnormalities.Unit appears to have been primed.Performed the hfo pressure decay leak test on the water side.The test ramps up the pressure in the water side to 45 psig and then checks for a decay.During the test there was a leak detected and the test failed.The device was not cut apart due to the "destructive analysis" field being left blank and not indicating being permitted.Reason for the return was confirmed for a water side leak.Correction b5.It was reported that during use a leak from the water line ports was identified with the mc3 nautilus extra corporeal membrane oxygenation (ecmo) oxygenator.The same leak did not appear in multiple packs.Plasma breakthrough did not occur.Patient blood loss did not occur because of the leak.An unplanned blood transfusion was not required because of the blood loss from the leak.The device was not continued in use and was replaced to complete the case.No patient complications have been reported as a result of this event.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.
Additional Manufacturer Narrative
Additional information b5.Medtronic received additional information that no anti coagulant used and no chemicals or drugs were used in the prime solution, just plasmalyte.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.
Additional Manufacturer Narrative
Device evaluation update: the device was cut apart.The water side was filled with colored water and there is leak in the bond by the water port.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: MC3 ECMO OXYGENATOR
• Common Device Name: OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24276438
• Report Number: 3011468686-2026-00015
• Device Sequence Number: 18623537
• Product Code: BYS
• UDI-Device Identifier: 10854916006888
• UDI-Public: (01)10854916006888(17)271231(10)2512293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K191935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/17/2026

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 Model Number: 48145
• Device Catalogue Number: 48145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 03/23/2026; Not provided; 06/01/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/06/2026; 03/24/2026; 05/20/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2025
• 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