MC3 ECMO OXYGENATOR
Report
- Report Number
- 3011468686-2025-00068
- Event Type
- Injury
- Date Received
- August 5, 2025
- Date of Event
- July 3, 2025
- Report Date
- August 21, 2025
- Manufacturer
- MC3 INC.
- Product Code
- BYS
- PMA / PMN Number
- K191935
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3: EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. G2: CITATION: AUTHOR: PHILIP S. BOONSTRA AND SEAN SUN TITLE: THE NAUTILUS AND NAUTILUS SMART OXYGENATORS IN THE ELSO REGISTRY, JANUARY 2020 ¿ APRIL 2025 LITERATURE REFERENCE: HTTPS://WWW.ELSO.ORG/ NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED INFORMATION VIA A STUDY REGARDING EXTRACORPOREAL LIFE SUPPORT USING NAUTILUS AND NON-NAUTILUS OXYGENATORS. ALL DATA WAS COLLECTED FROM THE EXTRACORPOREAL LIFE SUPPORT ORGANIZATION REGISTRY. THE DATA INCLUDED IN THE STUDY WAS FROM JANUARY 2020 TO 15 APRIL 2025. MULTIPLE PARTICIPATING CENTERS VOLUNTARILY CONTRIBUTE DATA ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) RUNS RETROSPECTIVELY COLLECTED FROM PATIENT RECORDS TO THE REGISTRY. THE STUDY POPULATION INCLUDED 1300 PEDIATRIC NAUTILUS OXYGENATOR RUNS AND THE PATIENTS ON WHICH NAUTILUS SMART ECMO OXYGENATOR WITH BALANCE BIOSURFACE OR NAUTILUS ECMO OXYGENATOR WITH BALANCE BIOSURFACE WERE USED WERE PREDOMINANTLY MALE; MEAN AGE 7 YEARS, (SERIAL, MODEL AND LOT NUMBERS WERE NOT PROVIDED). AMONG ALL PATIENTS, NO DEATHS OCCURRED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MODERATE AND SEVERE HEMOLYSIS, STROKE, HEMORRHAGIC STROKE AND DIFFUSE ISCHEMIC STROKE, POSITIVE RESPIRATORY TRACT, BLOOD AND URINE CULTURES. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS, DEVICE MALFUNCTIONS INCLUDED: HEAT EXCHANGER MALFUNCTIONS, AIR IN THE CIRCUIT, OXYGENATOR FAILURE, THROMBOSIS/CLOTS IN CIRCUIT COMPONENT, DECREASED EFFICIENCY OF GAS EXCHANGE, INCREASING RESISTANCE TO BLOOD FLOW, COAGULOPATHY WITH MEMBRANE LUNG AS KNOWN SOURCE, ACUTE OBSTRUCTION TO BLOOD FLOW, AND STRUCTURAL INTEGRITY ISSUES. BASED ON THE AVAILABLE INFORMATION, THESE MALFUNCTIONS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. MEDTRONIC RECEIVED AN UPDATE TO THE ABOVE-MENTIONED STUDY, IN WHICH THE NAUTILUS VITALFLOW OXYGENATOR WAS INCLUDED IN THE ANALYSIS. THE TIMEFRAME FOR THE COLLECTED DATA REMAINED THE SAME. THE RESULTS DID NOT DIFFERENTIATE BETWEEN THE SPECIFIC NAUTILUS DEVICES USED; ALL DATA WERE REPORTED UNDER THE GENERAL "ALL NAUTILUS" CATEGORY. THE STUDY POPULATION INCREASED FROM 1,300 TO 1,307. MEAN PATIENT DEMOGRAPHICS AND RELEVANT MEDICAL HISTORY REMAINED UNCHANGED. NO DEATHS WERE REPORTED AMONG ANY OF THE PATIENTS. IN THE UPDATED STUDY, AN INCREASE IN THE FOLLOWING ADVERSE EVENTS WAS OBSERVED, WHICH MAY BE ATTRIBUTED TO THE INCLUSION OF THE VITALFLOW OXYGENATOR: MODERATE AND SEVERE HEMOLYSIS. NO ADDITIONAL INFORMATION REGARDING DEVICE MALFUNCTIONS WAS NOTED FOR ANY OF THE DEVICES INCLUDED IN THE UPDATED STUDY. MEDTRONIC RECEIVED ADDITIONAL INFORMATION RELATED TO THE ABOVE-MENTIONED STUDY, IN WHICH THE AFFINITY CENTRIFUGAL PUMP (AP40) DEVICE WAS USED CONCOMITANTLY WITH THE UPDATED STUDY INCLUDING THE NAUTILUS VITALFLOW OXYGENATOR. ALL DATA WERE REPORTED UNDER THE GENERAL "NAUTILUS AND AP40" CATEGORY. THE TIMEFRAME FOR THE COLLECTED DATA REMAINED THE SAME. THE STUDY POPULATION DECREASED FROM 1,307 TO 11. MEAN PATIENT DEMOGRAPHICS AND RELEVANT MEDICAL HISTORY REMAINED UNCHANGED. NO DEATHS WERE REPORTED AMONG ANY OF THE PATIENTS. IN THE UPDATED STUDY, AN INCREASE IN THE FOLLOWING ADVERSE EVENTS WAS OBSERVED, WHICH MAY BE ATTRIBUTED TO THE INCLUSION OF THE VITALFLOW OXYGENATOR: MODERATE AND SEVERE HEMOLYSIS. IN ADDITION, THE STUDY DESCRIBED THE FOLLOWING DEVICE MALFUNCTIONS, POTENTIALLY RELATED TO THE INCLUSION OF THE AP40 PUMP DEVICE: CIRCUIT CHANGE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED INFORMATION VIA A STUDY REGARDING EXTRACORPOREAL LIFE SUPPORT USING NAUTILUS AND NON-NAUTILUS OXYGENATORS. ALL DATA WAS COLLECTED FROM THE EXTRACORPOREAL LIFE SUPPORT ORGANIZATION REGISTRY. THE DATA INCLUDED IN THE STUDY WAS FROM JANUARY 2020 TO 15 APRIL 2025. MULTIPLE PARTICIPATING CENTERS VOLUNTARILY CONTRIBUTE DATA ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) RUNS RETROSPECTIVELY COLLECTED FROM PATIENT RECORDS TO THE REGISTRY. THE STUDY POPULATION INCLUDED 1300 PEDIATRIC NAUTILUS OXYGENATOR RUNS AND THE PATIENTS ON WHICH NAUTILUS SMART ECMO OXYGENATOR WITH BALANCE BIOSURFACE OR NAUTILUS ECMO OXYGENATOR WITH BALANCE BIOSURFACE WERE USED WERE PREDOMINANTLY MALE; MEAN AGE 7 YEARS, (SERIAL, MODEL AND LOT NUMBERS WERE NOT PROVIDED). AMONG ALL PATIENTS, NO DEATHS OCCURRED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MODERATE AND SEVERE HEMOLYSIS, STROKE, HEMORRHAGIC STROKE AND DIFFUSE ISCHEMIC STROKE, POSITIVE RESPIRATORY TRACT, BLOOD AND URINE CULTURES. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS, DEVICE MALFUNCTIONS INCLUDED: HEAT EXCHANGER MALFUNCTIONS, AIR IN THE CIRCUIT, OXYGENATOR FAILURE, THROMBOSIS/CLOTS IN CIRCUIT COMPONENT, DECREASED EFFICIENCY OF GAS EXCHANGE, INCREASING RESISTANCE TO BLOOD FLOW, COAGULOPATHY WITH MEMBRANE LUNG AS KNOWN SOURCE, ACUTE OBSTRUCTION TO BLOOD FLOW, AND STRUCTURAL INTEGRITY ISSUES. BASED ON THE AVAILABLE INFORMATION, THESE MALFUNCTIONS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2635215 | MC3 ECMO OXYGENATOR | OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS | BYS | MC3 INC. | 48145 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Male | Hospitalization |