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

Model Number	48145E
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, within 10 minutes of ecmo bypass, the delta p was greater than 380 mmhg.Donor blood was given to the patient at the initiation of ecmo and the patient was not septic.There was no low gas exchange observed.Heparin was given, act was reported in the 200's.It was unknown if the patient had previously been on anti-coagulation therapy.The nautilus oxygenator was replaced with no impact to the patient.It was reported that a clot was observed in the oxygenator after the device had been replaced.There was no impact to the patient.
Additional Manufacturer Narrative
The device was returned for investigation.The high delta pressure could not be replicated; however, visual inspection confirmed a clot on the inlet side of the oxygenator.A high delta pressure would indicate a flow obstruction, which may have been a blood clot.The root cause of the alleged obstruction or clot is unknown.

• Brand Name: MC3 NAUTILUS ECMO OXYGENATOR
• Common Device Name: NAUTILUS 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: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 18539860
• Report Number: 3011468686-2024-00003
• Device Sequence Number: 15378517
• Product Code: BYS
• UDI-Device Identifier: 10854916006901
• UDI-Public: (01)10854916006901(17)240731(10)2206303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

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: 07/31/2024
• Device Model Number: 48145E
• Device Lot Number: 2206303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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