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	10/28/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that blood-tinged drainage was observed during an extra corporeal membrane oxygenation (ecmo) sigh procedure while using the mc3 nautilus ecmo oxygenator, device.Blood leakage was identified at the tubing connection of the device.The patient had been on ecmo with nautilus base since saturday the 25-oct-2025.On tuesday the 28-oct-2025 the customer had been sighing the oxygenator for 30 seconds every hour.All night it was clear.When the report was done at 7am the customer sighed together and it was clear drainage.At 8am the customer did it again and had lots of condensation build up but clear-more than previous times.When it was done at 9am the drainage was blood tinged and spotted the wash cloth on the ground.A circuit exchange was performed as a result of the event.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 same leak did not appear in multiple packs.Plasma breakthrough did not occur. no patient complications have been reported as a result of this event.Medtronic received additional information that there was no visible damage to the device.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the tie-band on the qb-inlet and outlet tubing connections are loose.Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there were no leaks observed from the fiber bundle or the qb-inlet and outlet tubing connections.Reason for the return was not confirmed.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
Correction d4.5 unique identifier (udi)# additional information d4.2 expiration date, d4.D lot # h4.Device mfg date: this information was added.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: 23462097
• Report Number: 3011468686-2025-00110
• Device Sequence Number: 21407525
• Product Code: BYS
• UDI-Device Identifier: 10854916006888
• UDI-Public: (01)10854916006888(17)270930(10)2509126
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 12/08/2025

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: 2509126
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 12/03/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/28/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown