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

Model Number	48135
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a nautilus extra corporeal membrane oxygenation (ecmo) oxygenator, it was reported that there was a leak from the exhaust port on the bottom of the oxygenator.Patient blood loss did not occur because of the leak.An unplanned blood transfusion was not required.The leak originated from the component.The same leak did not appear in multiple packs.Plasma breakthrough did not occur.They administrated 10,000 units of heparin iv bolus at the time of cannulation and no additional medication¿s were added in the circuit.The device was immediately replaced to complete the procedure.There was no adverse patient effect associated with 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
B.5.Medtronic received additional information that no heater-cooler in use during blood leak, cardioquip was used.The perceived rate of leak was an intermittent steady drip.The device was used immediately prior to the leak.The circuit was primed for approximately two days.The circuit was primed with saline.Update to a.Patient information.Update to d.4.Serial number device evaluation: visual inspection showed evidence of a fiber leak with blood reside in the o2 outlet port.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 was a leak observed from the o2 outlet port.Reason for return was 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 b5: medtronic received information that during use of a nautilus extra corporeal membrane oxygenation (ecmo) oxygenator, it was reported that there was a leak from the exhaust port on the bottom of the oxygenator.An unplanned blood transfusion was not required.The leak originated from the component.The same leak did not appear in multiple packs.Plasma breakthrough did not occur.They administrated 10 ,000 units of heparin iv bolus at the time of cannulation and no additional medication¿s were added in the circuit.The device was immediately replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that no heater-cooler in use during blood leak, cardioquip was used.The perceived rate of leak was an intermittent steady drip.The device was used immediately prior to the leak.The circuit was primed for approximately two days.The circuit was primed with saline.Medtronic received additional information that there was a blood leak.The amount was minimal due to an immediate oxygenator exchange completed upon noticing the blood leak.Correction d4: unique identifier (udi) # format updated.Correction h6: patient codes (ime/annex e) 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: 21432038
• Report Number: 3011468686-2025-00013
• Device Sequence Number: 14629650
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)260630(10)2406320
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K191935
• Number of Events Summarized: 1
• Summary Report (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): 07/28/2025

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 Expiration Date: 06/30/2026
• Device Model Number: 48135
• Device Catalogue Number: 48135
• Device Lot Number: 2406320
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 07/08/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/01/2025; 07/28/2025
• Date Device Manufactured: 06/30/2024
• 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 Age: 28 YR
• Patient Sex: Male
• Patient Weight: 67 KG