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

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	09/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, after 30 minutes use of a nautilus smart oxygenator there was a reported blood gas path leak.There was no adverse patient effect.
Additional Manufacturer Narrative
The device was not returned for investigation.Without evaluation of the device a root cause can be determined.
Additional Manufacturer Narrative
The device was returned for evaluation.The blood leak in the returned device was confirmed.The cause is a fiber leak.
Event or Problem Description
This is follow-up to the previous report 3011468686-2023-00018.Additional information indicated the oxygenator was used for an hour after the reported blood gas path leak.The device was changed out.It was reported that approximately 300ml of blood was lost before and during the change out.The clnician reported that blood products were administered to the patient.No further information was reported.

• 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: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 17981446
• Report Number: 3011468686-2023-00018
• Device Sequence Number: 3470879
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)250531(10)2305145
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 48135
• Device Lot Number: 2305145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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