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

Model Number	48145
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that clot formation occurred with the mc3 nautilus extracorporeal membrane oxygenation (ecmo) oxygenator during use.It occurred from (b)(6).The device was used to complete the procedure.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
Medtronic received additional information that the device was used for 7-8 days prior to the event.Priming drugs used was calcium gluconate, sodium bicarb, 25% albumin and heparin.Small fibrin, thrombus was noted in connectors.The clots grew slowly.Anticoagulation was maintained based on standard protocol.The customer did not change the circuit or oxygenator because of this clot formation; functionality of the oxygenator was not "affected." the entire circuit is always changed at the customers institution.Low gas exchange was not observed.The patient's hematocrit at the initiation of ecmo was 41.5.The "patient's" hematocrit at the time the event was first suspected was 35-36.Heparin dosing is monitored using antixa (0.6-0.8) and atiii (>60%).The patient was not previously on heparin or other anti-coagulant therapy.The volume of prime solution in the circuit prior to initiation of ecmo was 700-800ml.Donor (packed red blood cells) prbcs, platelets and cryo were given to the patient.Prbcs resided in the circuit prior to the initiation of ecmo.The patient was not septic at anytime during or immediately prior to the ecmo run.A sorin s5 perfusion style rollerhead pump was utilized with a tubing pack made by medtronic with a cortiva tubing coating.There is a bridge present with approximately 10 connector points total for access pre and postmo.10-12 is referring to the location of clot formation based on the hands of a clock.Clot formation occurred between 10 and 12 o'clock.Device evaluation summary: visual inspection shows evidence of a clot at the top pf both sides of the device.Reason for return was visually confirmed by the clot residue.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
H.6.Fdc code updated d.4.Udi 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: 22043352
• Report Number: 3011468686-2025-00034
• Device Sequence Number: 8880135
• Product Code: BYS
• UDI-Device Identifier: 10854916006888
• UDI-Public: (01)10854916006888(17)270228(10)2502230
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/21/2025

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: 2502230
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 08/20/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/18/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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