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

Model Number	48145E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device in transit from user facility, will be investigated once received.
Event or Problem Description
Fluid leak out of gas outlet port.Device changed out and replaced with another nautilus oxygenator.

• Brand Name: MC3 NAUTILUS ECMO OXYGENATOR
• Common Device Name: NAUTILUS OXGENATOR
• 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: 12969663
• Report Number: 3011468686-2021-00013
• Device Sequence Number: 17190993
• Product Code: BYS
• UDI-Device Identifier: 10854916006901
• UDI-Public: 01108549160069011723063010
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: 06/30/2023
• Device Model Number: 48145E
• Device Catalogue Number: 48145E
• Device Lot Number: 2106109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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