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

Model Number	48135
Medical Device Problem Codes	Fluid/Blood Leak (1250); Structural Problem (2506)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypoxia (1918)
Date of Event	02/13/2026
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
Medtronic received information that during use of an mc3 nautilus extra corporeal membrane oxygenation (ecmo) oxygenator, it was reported that blood was seen dripping from the case on the bottom of the membrane approximately 24 hours after veno-venous support was started.There was also an odd observation on the venous filling vanes when the customer started to use it, it was not clear if this was related to the leak.The device was changed out to a new one to continue the support.The patient experienced lower oxygenation during the change out lasting a couple of minutes.As patient is still on support it is unclear if there's any effect on the patient.See attached photos.  there was no further adverse patient effect associated with this event.Medtronic received additional information that the low oxygenation level was due to stopping flow to change the defective membrane, so it was corrected when flow was started with the new membrane.The patient remains on vv ecls (veno-venous extracorporeal life support).The blood loss is guessed to be around a few hundred mls due to the leak itself.As it is hard to tell, as it leaked onto the holder and floor over time.The circuit blood was drained and washed and returned to the patient.The odd observation on the venous filling vanes refers to the anomalous view of the heat exchanger fibers on the filling vanes medtronic received additional information that there was no blood transfusion needed at the time the nautilus leaked blood and was changed out.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed no outward signs of physical damage or abnormalities.Pressure integrity testing was performed at 3 l/min with 23 psi (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there were no leaks observed from the device including the fiber bundle.The device was cut apart and there was some blood residue along the bottom of the device.The customer has provided photos of the leak from the bottom of the device.The reason for the return was visually confirmed by the photos provided by the customer.Correction h8 (usage of device): this field has been updated.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: 24427492
• Report Number: 3011468686-2026-00019
• Device Sequence Number: 9730798
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)260831(10)2408310
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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: 08/31/2026
• Device Model Number: 48135
• Device Catalogue Number: 48135
• Device Lot Number: 2408310
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 06/23/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/16/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2024
• 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