MC3 Nautilus (tm) Smart ECMO Module 48135Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10854916006871), received between Jun 3, 2022 and Sep 15, 2026 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 11, 2023Open, Classified

   May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer

   Z-1310-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak; Material Deformation

  Medtronic received information that after crystalloid priming but prior to blood priming, the MC3 Nautilus extracorporeal membrane oxygenation (ECMO) oxygenator leaked. The leak occurred from the unit itself, not from the connections. No patient blood loss, unplanned blood transfusion, or plasma breakthrough occurred. The device was replaced. There was no patient involvement, so no adverse effect occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769256 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak; Structural Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT BLOOD WAS SEEN DRIPPING FROM THE CASE ON THE BOTTOM OF THE MEMBRANE APPROXIMATELY 24 HOURS AFTER VENO-VENOUS SUPPORT WAS STARTED. THERE WAS ALSO AN ODD OBSERVATION ON THE VENOUS FILLING VANES WHEN THE CUSTOMER STARTED TO USE IT, IT WAS NOT CLEAR IF THIS WAS RELATED TO THE LEAK. THE DEVICE WAS CHANGED OUT TO A NEW ONE TO CONTINUE THE SUPPORT. THE PATIENT EXPERIENCED LOWER OXYGENATION DURING THE CHANGE OUT LASTING A COUPLE OF MINUTES. AS PATIENT IS STILL ON SUPPORT IT IS UNCLEAR IF THERE'S ANY EFFECT ON THE PATIENT. SEE ATTACHED PHOTOS.  THERE WAS NO FURTHER ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOW OXYGENATION LEVEL WAS DUE TO STOPPING FLOW TO CHANGE THE DEFECTIVE MEMBRANE, SO IT WAS CORRECTED WHEN FLOW WAS STARTED WITH THE NEW MEMBRANE. THE PATIENT REMAINS ON VV ECLS (VENO-VENOUS EXTRACORPOREAL LIFE SUPPORT). THE BLOOD LOSS IS GUESSED TO BE AROUND A FEW HUNDRED MLS DUE TO THE LEAK ITSELF. AS IT IS HARD TO TELL, AS IT LEAKED ONTO THE HOLDER AND FLOOR OVER TIME. THE CIRCUIT BLOOD

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoxia

  MAUDE report 24427492 ↗
• MalfunctionJan 19, 2026Air/Gas in Device

  IT WAS REPORTED THAT AIR, BUBBLES, AND FOAM WERE OBSERVED IN THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION PRIOR TO USE, WITH AIR ENTRAINED THROUGH THE HYDROPHOBIC MEMBRANE WHILE THE CIRCUIT WAS OFF. VISIBLE AIR WAS PRESENT IN THE SYSTEM/TUBING. THERE WAS NO PURGE LINE. SUCTION AND VENTING WAS NOT USED AND THE RECIRCULATION PORT WAS NOT USED DURING THE CASE OR PRIMING. THERE WAS NO PLACEMENT ISSUE WITH THE CANNULA, THE VENOUS LINE WAS NOT PARTIALLY OBSTRUCTED, AIR WAS NOT OBSERVED IN THE VENOUS LINE, VACUUM ASSISTED VENOUS DRAINAGE WAS NOT USED, AND THERE WERE NO IMPLEMENTS ON THE VENOUS LINE. THE BUBBLES AND FOAM DID NOT STOP, AND USE OF THE DEVICE WAS NOT CONTINUED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108728 ↗
• MalfunctionJan 13, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, THE CUSTOMER REPORTED A LEAK, SPECIFICALLY ORIGINATING FROM A COMPONENT RATHER THAN A TUBING CONNECTION. THE LEAK WAS IDENTIFIED AS A WATER LEAK AND THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THERE WAS NO PATIENT BLOOD LOSS ASSOCIATED WITH THE LEAK, NO UNPLANNED BLOOD TRANSFUSION WAS REQUIRED, AND NO PLASMA BREAKTHROUGH OCCURRED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051956 ↗
• MalfunctionDec 23, 2025Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THERE WAS A CRACK ON THE INLET PORT OF THE OXYGENATOR. A COMPLETE BREAK DID NOT OCCUR. SEE ATTACHED PHOTOS/VIDEO. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875544 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A LEAK WAS IDENTIFIED AT THE EXHAUST PORT OF THE MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR DURING USE. BIVAL WAS USED AS THE ANTI-COAGULANT AND PLASMALYTE WAS USED DURING THE CASE. THERE WAS NO PATIENT BLOOD LOSS OR PLASMA BREAKTHROUGH DUE TO THE LEAK, AND AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED. PLASMA BREAKTHROUGH DID NOT OCCUR. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. USE OF THE DEVICE WAS CONTINUED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT WHILE ON ECMO (EXTRA CORPOREAL MEMBRANE OXYGENATION) AND AWAITING A LUNG TRANSPLANT, A PATIENT EXPERIENCED CARDIAC ARREST AND DIED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S DEATH WAS NOT BELIEVED TO BE LINKED TO THIS EVENT AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801587 ↗
• MalfunctionSep 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR HAD A DEFORMED INLET CONNECTOR PRIOR TO USE. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO CRACKS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070658 ↗
• MalfunctionJul 17, 2025Gas Output Problem; Obstruction of Flow; Gas Output Problem; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THERE WAS A GAS TRANSFER, FIBRIN AND CLOTTING ISSUE. THERE WAS LOW PAO2 (PARTIAL PRESSURE OF OXYGEN) OBSERVED. THE DEVICE WAS NOT DAMAGED. THERE WERE CLOTS NOTED ON THE PRE-OXYGENATOR SIDE AT 9 AM, 10 AM AND 12 AM. FIBRIN WAS NOTED FROM 11 TO 1 PM. THE OXYGENATOR WAS INITIATED ON (B)(6) 2025 AT 13.00 PM AS A REPLACEMENT FOR THE FAILING OXYGENATOR ON ECMO DAY 9. NO HEPARIN WAS ADMINISTRATED FOR THE CHANGE OUT. THERE WAS A CONTINUOUS INFUSION OF BIVALIRUDIN AT 0.0782MG/KG/HR. THE THERAPEUTIC RANGE GOAL FOR THE PTT (PARTIAL THROMBOPLASTIN) WAS 50 TO 70 SECONDS. THE INITIAL FLOW WAS AT 6 L/MIN (EQUIVALENT TO THE PREVIOUS OXYGENATOR FLOW). THE PUMP WAS SET TO 3975 RPM (REVOLUTIONS PER MINUTE), AND THE SWEEP GAS FLOW WAS SET TO 6. THE FRACTION OF DELIVERED OXYGEN (FDO2) WAS AT 100%. THE INITIAL PRESSURES PRE-OXYGENATOR AND POST-OXYGENATOR WERE 284 MMHG AND 246 MMHG, RESPECTIVELY. THE DELTA P WAS 38 MMHG. THE POST-OXYGENATOR ABG (ARTERIAL BLOOD GAS) SHOWED THE PH AT 7.4, THE PACO2 (PARTIAL PRESSURE OF CARBON DIOXIDE) AT 45 MMHG AND PAO2 AT 404 MMHG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529237 ↗
• MalfunctionJul 8, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE HEAT EXCHANGER WAS NOT WORKING. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED AN ADDITIONAL DEVICE FOR ANALYSIS; HOWEVER, IT WAS CONFIRMED THAT THE CUSTOMER DID NOT WANT TO USE THE SECOND DEVICE SINCE IT HAS THE SAME LOT NUMBER AS THE FIRST DEVICE THAT WAS NOT WORKING. THE SECOND DEVICE WAS NOT USED OR OPENED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS ON ECMO FOR ABOUT 12 HOURS PRIOR TO THE CUSTOMER NOTICING THE HEAT EXCHANGER WAS NOT WORKING. THE CUSTOMER SAID THEY TESTED THE FLOW THROUGH THE OXYGENATOR WATER PATH BEFORE INITIATING. THE DEVICE WAS REPLACED AFTER ABOUT 12 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435964 ↗
• MalfunctionJun 3, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING SETUP AND PRIMING OF THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, A FLUID LEAK WAS OBSERVED IN THE PINK CAP, AND UPON EXAMINATION, A TINY HOLE WAS SEEN IN THE END OF THE CAP. THE CAP WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130463 ↗
• MalfunctionFeb 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE EXHAUST PORT ON THE BOTTOM OF THE OXYGENATOR. PATIENT BLOOD LOSS DID NOT OCCUR BECAUSE OF THE LEAK. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED. THE LEAK ORIGINATED FROM THE COMPONENT. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. PLASMA BREAKTHROUGH DID NOT OCCUR. THEY ADMINISTRATED 10,000 UNITS OF HEPARIN IV BOLUS AT THE TIME OF CANNULATION AND NO ADDITIONAL MEDICATION¿S WERE ADDED IN THE CIRCUIT. THE DEVICE WAS IMMEDIATELY REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432038 ↗
• MalfunctionDec 5, 2024Crack; Packaging Problem; Crack; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE SHELL AND OXYGEN INLET PORT WERE BROKEN. THE SIZE OF THE CRACK WAS LARGE. A COMPLETE CRACK/BREAK OCCURRED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A SMALL DING IN THE PACKAGING, BUT IT WAS NOT SIGNIFICANT. THE OUTER SHELL OF THE DEVICE AROUND THE SCREEN WAS BROKEN/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851518 ↗
• MalfunctionOct 20, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATOR, IT WAS REPORTED THAT ON INITIALIZATION, THE DELTA-P WAS READING LOW WHEN THE P-OUT PRESSURE APPEARED HIGHER THAN THE P-IN PRESSURE. AT THAT TIME, THE VENOUS OXYGEN SATURATION (SVO2) AND THE ARTERIAL OXYGEN SATURATION (SAO2) WERE AS EXPECTED. THE FLIP SCREEN BUTTON WAS GREYED OUT AND WOULD NOT WORK. UPON PLACING THE DEVICE ON THE PATIENT, IT DID APPEAR NORMAL WITH THE PLAY SCREEN ON STARTUP/TURNING ON. AFTER ABOUT 15 MINUTES, THE ISSUE RESOLVED AND THE P-IN WAS HIGHER THAN THE P-OUT. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO ERROR CODES DISPLAYED. THE DEVICE POWER WAS NOT CYCLED AT THE TIME OF THE ISSUE. THE CUSTOMER ATTEMPTED TO POWER CYCLE THE DEVICE BEFORE SENDING IT BACK ONTO THE BATTERY. THE DEVICE WAS PREVIOUSLY OFF AND IT WAS PRIMED FOR 2 WEEKS. THE DEVICE WAS PLACED ON THE PATIENT WITH THE SCREEN OFF. IT WAS TURNED ON AND THE PLAY SCREEN APPEARED AND INITIALIZED AS PER NORMAL. IT IMMEDIATELY DISPLAYED A LO ALARM FOR DELTA P. THERE WAS NO LIQUID SPILLED ON TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490340 ↗
• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THERE WAS LEAK OBSERVED THROUGH THE EXHAUST PORT OF THE DEVICE. THE LEAK CAME FROM THE COMPONENT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481810 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT UPON PRIMING, THE DEVICE BEGAN TO LEAK FROM THE GAS EXHAUST PORT AT A RAPID RATE. THE LEAKING CAME FROM THE NAUTILUS SMART COMPONENT. THE LEAK DID NOT OCCUR IN MULTIPLE PACKS. PLASMA BREAKTHROUGH DID NOT OCCUR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407532 ↗
• InjuryOct 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE DEVICE WOULD NOT OXYGENATE. THE CUSTOMER REPORTED A GAS TRANSFER ISSUE AND EXPERIENCED LOW PO2. CLOTTING/THROMBUS/FIBRIN WAS NOT OBSERVED IN THE CIRCUIT. THERE WAS NO DAMAGE OBSERVED TO THE DEVICE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. INTERVENTION WAS REQUIRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER FIRST ATTEMPTED TO CHANGE OUT THE OXYGEN AND AIR TUBING, THEN WHERE THEY WERE PLUGGED INTO THE WALL, THE CUSTOMER TRIED TO SWITCH TO A BLENDER WHICH DID NOT WORK. THE LAST INTERVENTION WAS TO CHANGE OUT THE OXYGENATOR. THE PATIENT CAME OFF OF PUMP SUCCESSFULLY A WEEK LATER. THE CUSTOMER WAS UNSURE WHAT WAS MEANT BY PUMP RECORD, THERE IS A RECORD BUT HAD NOT STARTED IT YET SINCE WE HAD JUST GONE ON PUMP. THE CUSTOMER ONLY OBTAINED A POST OXYGENATOR GAS TO SEE WHAT THE POST PO2 WAS. PH 7.15, CO2 49, PO2 65, -12, HCO3 17, SO2 86. THIS WAS ON A SWEEP OF 100 AND FIO2 100%. PATIENT CO2 BEFORE GOING ON WAS IN THE 30S. THE CUSTOMER HAD JUST STARTED BIVALIRUDIN ON OUR PUMP SIDE WITH THE INITIATION OF EXTRA CORPOREAL

  Patient problems: Respiratory Insufficiency

  MAUDE report 20377508 ↗
• MalfunctionAug 22, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE INFORMATION ON THE SCREEN WOULD NOT OPEN AND IT WAS BLANK.  THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042580 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A NAUTILUS SMART EXTRACORPOREAL MEMBRANE OXYGENATION, IT WAS REPORTED THAT AIR WAS OBSERVED IN THE ARTERIAL SIDE TOP OF THE MEMBRANE ON THE SECOND DAY OF THE PROCEDURE. IT WAS DURING AN INTERVENTIONAL LUNG ASSIST (ILA) PROCEDURE. THE LINES WERE CLAMPED, AND THE AIR WAS REMOVED BY DRAWING ON THE ARTERIAL PORT. THE CUSTOMER STATED THAT THE ISSUE APPEARED TO BE MICRO BUBBLES SLOWLY APPEARING IN THE ARTERIAL SIDE. THE AIR WAS DRAWN OFF FOR A SECOND TIME AND THE ISSUES WENT AWAY FOR A FEW HOURS. HOWEVER, THE ISSUE REAPPEARED OVERNIGHT. THE PATIENT WAS STILL ON SUPPORT; THEREFORE, IT WAS UNCLEAR IF THEY WERE AFFECTED BY THE ISSUE. THE CUSTOMER STATED THAT THE PROCEDURE OF AN INTERVENTIONAL LUNG ASSIST WAS NOT THE TYPICAL USE FOR THE DEVICE, BUT IT SHOULD NOT ENTRAIN AIR IN ANY CASE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609650 ↗
• MalfunctionMar 28, 2024Infusion or Flow Problem; Infusion or Flow Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990033 ↗
• MalfunctionMar 19, 2024Infusion or Flow Problem; Infusion or Flow Problem

  ON 16-FEB-2024, AFTER LESS THAN 1 HOUR USE OF A NAUTILUS SMART OXYGENATOR, THERE WAS A DECREASE IN FLOW AND AN INCREASE IN DELTA PRESSURE. REPORTED AS A CLOTTING/FLOW ISSUE. THE PATIENT HAD PREVIOUSLY BEEN ON HEPARIN THERAPY. THE OXYGENATOR WAS REPLACED WITH NO FURTHER ISSUES. THE PATIENT WAS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED ON 21-MAR-2024, THROUGH MDR MW5152343, INDICATED THE OXYGENATOR INCREASED IN DELTA PRESSURE FROM THE 20S TO THE 80S WITH A SUBSEQUENT DROP IN SYSTEMIC FLOWS FROM THE MID 3S TO MID 2S, WITH INCREASED REVOLUTIONS PER MINUTE, FLOWS WERE RESPONSIVE. THERE WAS VISIBLE DEBRIS ON THE INLET SIDE OF THE OXYGENATOR, NOTHING NOTED ON THE OUTLET SIDE. AT 10AM THE OXYGENATOR WAS CHANGED WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933550 ↗
• MalfunctionOct 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, A FEMALE PATIENT (41.7KG) WAS TREATED WITH VV ECMO. BLOOD FLOW WAS 2.7 LPM, GAS FLOW WAS 2 LPM, AND THE DELTA P WAS BETWEEN 11-16 MMHG. SHORTLY AFTER INITIATING ECMO THE NAUTILUS SMART OXYGENATOR BEGAN TO LEAK BLOOD, 10-20ML, FROM THE GAS EXHAUST PORT. THE DEVICE WAS CHANGED IMMEDIATELY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18033327 ↗
• InjuryOct 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981446 ↗
• MalfunctionSep 20, 2023Infusion or Flow Problem; Infusion or Flow Problem

  ON 22-AUG-2023, DURING USE OF A NAUTILUS SMART OXYGENATOR IT WAS REPORTED THAT THE HEAT EXCHANGER WAS NOT WORKING. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION, RECEIVED ON 20-SEP-2023, INDICATED THE PATIENT WAS ON ECMO FOR ABOUT 12 HOURS PRIOR TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784635 ↗
• MalfunctionSep 15, 2023Infusion or Flow Problem; Infusion or Flow Problem

  ON (B)(6) 2023, ECMO WAS INITIATED ON A PATIENT. ON (B)(6) 2023, AFTER 3 DAYS OF USE WITH A NAUTILUS OXYGENATOR, THERE WAS NO HEAT TRANSFER. THE PATIENT WAS MAINTAINING A TEMPERATURE OF 32 DEGREES WITH THE HEATER-COOLER DEVICE SET AT 37 DEGREES. IT WAS REPORTED THAT AN ALARM OCCURRED INDICATING, "TEMPERATURE DIFFERENTIAL ERROR. THIS ERROR CAN BE CAUSED BY BLOCKED FLOW. PLEASE CHECK ALL CONNECTORS, HOSES AND VALVES IN THE WATER CIRCUIT". THE TUBING AND HEATER-COOLER DEVICE WERE REPLACED. THE ALARM CONTINUED AND THE HEATER-COOLER WAS REPRIMED AND RECONNECTED. THE PATIENT'S TEMPERATURE WAS BELOW 32 DEGREES AND THE CIRCUIT WAS CHANGED OUT. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Alteration in Body Temperature

  MAUDE report 17759145 ↗
• MalfunctionAug 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, ECMO WAS INITIATED AND A NAUTILUS SMART OXYGENATOR BEGAN LEAKING BLOOD FROM THE GAS EXHAUST PORT. THE OXYGENATOR CONTINUED TO FLOW AND OXYGENATE. WITHIN 30 MINUTES THE OXYGENATOR WAS CHANGED OUT. IT WAS ESTIMATED THAT THE OXYGENATOR LEAKED APPROXIMATELY 60 TO 100ML OF BLOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17552544 ↗