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

Model Number	48135
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a two-day old male, weight 2 kg, was placed on ecmo therapy with a nautilus smart oxygenator.Thirty-five minutes prior to being placed on ecmo, the patient received 50 units heparin per kg.The hemochron act-lr was greater than 400.Within 3 minutes of being placed on ecmo, adequate blood flow was not able to be achieved.The pre-membrane pressure was 380 mmhg, post-membrane pressure was 60 mmhg, and the delta p was 320 mmhg.The reporter suspected the oxygenator clotted off.The oxygenator was replaced.The patient was reported as alive with no injury.
Additional Manufacturer Narrative
The device was returned for investigation.The decreased blood flow and increase in delta pressure could not be confirmed during device evaluation.Visual inspection of the returned device confirmed a small clot on the inlet side of the oxygenator, which suggests the clot came from an upstream source.Definitive root cause of the clot is unknown; however, the low flow and high delta pressure reported may have been due to a clot.Based on the information, the device performed as expected when introduced to clots from an upstream source.There is no device issue found in relation to this occurence,.

• 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: 18990033
• Report Number: 3011468686-2024-00008
• Device Sequence Number: 20734209
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)251130(10)2311151
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 03/18/2024

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: 11/30/2025
• Device Model Number: 48135
• Device Lot Number: 2311151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Weight: 2 KG