MAUDE Adverse Event Report: MC3 INC. MC3 NAUTILUS SMART ECMO OXYGENATOR; NAUTILUS SMART OXYGENATOR

Model Number	48135
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during use of an mc3 nautilus extra corporeal membrane oxygenation (ecmo) oxygenator, it was reported that the device would not oxygenate.The customer reported a gas transfer issue and experienced low po2.Clotting/thrombus/fibrin was not observed in the circuit.There was no damage observed to the device.The device was replaced to complete the procedure.Intervention was required.Medtronic received additional information that the customer first attempted to change out the oxygen and air tubing, then where they were plugged into the wall, the customer tried to switch to a blender which did not work.The last intervention was to change out the oxygenator.The patient came off of pump successfully a week later.The customer was unsure what was meant by pump record, there is a record but had not started it yet since we had just gone on pump.The customer only obtained a post oxygenator gas to see what the post po2 was.Ph 7.15, co2 49, po2 65, -12, hco3 17, so2 86.This was on a sweep of 100 and fio2 100%.Patient co2 before going on was in the 30s.The customer had just started bivalirudin on our pump side with the initiation of extra corporeal membrane oxygenation (ecmo).The patient did receive a heparin dose for cannulation.The patient only had a hematocrit drawn 3 hours before initiation and it was 44.3.Then the hematocrit on our gas machine was 40 and that was with the blood gas drawn 9 minutes after initiation.This was the first oxygenator used and it was just taken out of the box and placed into the circuit.The customer had a unit infusing on the patient side at initiation plus a unit infusing on the circuit side at initiation.So 2 units of prbc infusing.The patient was not septic at any time during or immediately prior to the ecmo run.The patient was only on ecmo for approximately 5 minutes.The customer is unsure how the gas transfer issue was resolved, the oxygenator was changed out.
Additional Manufacturer Narrative
The complaint device was tested for gas transfer and the measured oxygen and carbon dioxide transfer rates were above the performance requirements.

• Brand Name: MC3 NAUTILUS SMART ECMO OXYGENATOR
• Common Device Name: NAUTILUS SMART OXYGENATOR
• 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: tanya pockrandt ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 20377508
• Report Number: 3011468686-2024-00022
• Device Sequence Number: 3745993
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)260531(10)2405320
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/31/2026
• Device Model Number: 48135
• Device Lot Number: 2405320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown