MC3 Nautilus(tm) ECMO Oxygenator 48145Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10854916006888), received between Sep 11, 2020 and Sep 11, 2026 — classified as 3 deaths, 4 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 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-1309-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fluid/Blood Leak

  Medtronic received information that during use of a MC3 Nautilus extracorporeal membrane oxygenation (ECMO) oxygenator, a blood leak was observed from the oxygenator arterial blood outlet port component, reportedly not associated with the tubing connected to the port. Patient blood loss occurred; the amount was unavailable. The device was replaced to complete the case. There was no adverse patient effect associated with this event.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50727337 ↗
• MalfunctionMay 22, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO), THE CUSTOMER REPORTED A DAMAGED PORT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BLOOD OUTLET PORT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253474 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A OXY NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATOR, IT WAS REPORTED THAT A LEAK WAS OBSERVED AT THE EXHAUST OF THE NAUTILUS. THERE WAS BLOOD LOSS DUE TO THE LEAK, AND THE AMOUNT OF BLOOD LOSS WAS UNKNOWN. THE CUSTOMER STATED THAT AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS AND THERE WAS NO, PLASMA BREAKTHROUGH. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24997586 ↗
• MalfunctionApr 14, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE OXYGENATOR BEGAN LEAKING BLOOD IMMEDIATELY UPON BEING CONNECTED TO THE MACHINE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24869542 ↗
• MalfunctionMar 23, 2026Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED A FLOW OBSTRUCTION. 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 24670775 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK FROM THE WATER LINE PORTS WAS IDENTIFIED WITH THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. PLASMA BREAKTHROUGH DID NOT OCCUR. PATIENT BLOOD LOSS DID NOT OCCUR BECAUSE OF THE LEAK. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE BLOOD LOSS FROM THE LEAK. THE DEVICE WAS NOT CONTINUED IN USE AND WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276438 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE ,A LEAK OCCURRED WITH THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR DEVICE, SPECIFICALLY AT THE BOTTOM NEAR THE MOLDING, WHERE ONLY WATER WAS LEAKING.PATIENT BLOOD LOSS DID NOT OCCUR BECAUSE OF THE LEAK.THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS.PLASMA BREAKTHROUGH DID NOT OCCUR.THE USE OF THE DEVICE WAS NOT CONTINUED.THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276088 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A OXY NAUTILUS ECMO, IT WAS REPORTED THAT THE OUTER BROWN CÁRDBOARD BOX WAS CLEARLY CRUSHED ON THE CORNER UPON DELIVERY. THE CUSTOMER STATED THAT WHEN THEY OPENED THE BOX, THEY OBSERVED THAT THE INNER STERILE TRAY WAS DAMAGED AND UNSTERILE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS SEALED/LOCATED IN THE SEAL BUT THE CORNER WAS DENTED AND THE TYVEK LID WAS SLIGHTLY PEELED OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144054 ↗
• MalfunctionJan 12, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, THE CUSTOMER REPORTED A HOLE IN THE PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039391 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD-TINGED DRAINAGE WAS OBSERVED DURING AN EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) SIGH PROCEDURE WHILE USING THE MC3 NAUTILUS ECMO OXYGENATOR, DEVICE. BLOOD LEAKAGE WAS IDENTIFIED AT THE TUBING CONNECTION OF THE DEVICE. THE PATIENT HAD BEEN ON ECMO WITH NAUTILUS BASE SINCE SATURDAY THE 25-OCT-2025. ON TUESDAY THE 28-OCT-2025 THE CUSTOMER HAD BEEN SIGHING THE OXYGENATOR FOR 30 SECONDS EVERY HOUR. ALL NIGHT IT WAS CLEAR. WHEN THE REPORT WAS DONE AT 7AM THE CUSTOMER SIGHED TOGETHER AND IT WAS CLEAR DRAINAGE. AT 8AM THE CUSTOMER DID IT AGAIN AND HAD LOTS OF CONDENSATION BUILD UP BUT CLEAR-MORE THAN PREVIOUS TIMES. WHEN IT WAS DONE AT 9AM THE DRAINAGE WAS BLOOD TINGED AND SPOTTED THE WASH CLOTH ON THE GROUND. A CIRCUIT EXCHANGE WAS PERFORMED AS A RESULT OF THE EVENT. PATIENT BLOOD LOSS DID NOT OCCUR BECAUSE OF THE LEAK. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE BLOOD LOSS FROM THE LEAK. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. PLASMA BREAKTHROUGH DID NOT OCCUR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO VISIBLE DAMAGE TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462097 ↗
• MalfunctionSep 16, 2025Fluid/Blood Leak

  POST OXYGENATOR CHANGE OUT, BLOOD LEAK NOTICED OUT OF CAP ON POST MEMBRANE. PT HAD TO BE CLAMPED OFF OF ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION] BRIEFLY WHILE CAP CHANGED OUT. NOTED TO HAVE HAPPENED ONCE BEFORE IN THE PAST. MANUFACTURER RESPONSE FOR OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS, MC3 NAUTILUS(TM) ECMO OXYGENATOR (PER SITE REPORTER). THEY WILL REPORT AND APOLOGIZED FOR INCONVENIENCE.

  Patient problems: Insufficient Information

  MAUDE report 23063050 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A OXY NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION, IT WAS REPORTED THE BACKUP BLOOD CHANNEL PORT ON THE OUTLET SIDE WAS LEAKING BLOOD, AND TIGHTENING THE PORT DID NOT RESOLVE THE PROBLEM. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT;

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

  MAUDE report 22931798 ↗
• MalfunctionJul 8, 2025Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED PRIOR TO SETTING IT ON PATIENT, THE WATER WASN'T FLOWING THROUGH THE DEVICE FROM THE HEATER COOLER. THE CUSTOMER THEN TRIED TWO DIFFERENT CARDIO QUIP HEATER COOLERS AND AGAIN NOTED WATER WAS NOT FLOWING THROUGH THE NAUTILUS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CIRCUIT WAS PRIMED FOR ABOUT 2 HOURS AT MOST. THE CIRCUIT WAS PRIMED WITH SALINE. THERE WERE NO ANTI-COAGULANTS OR DRUGS USED DURING PRIME. THERE WERE NO DAMAGE TO THE PACKAGING. THERE WAS NO DAMAGE IDENTIFIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435793 ↗
• MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE EXHAUST PORT OF THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR. THE LEAK WAS NOTICED WHEN THE PRIME CENTRAMAG CIRCUIT WAS BEING PACKED UP FOR TRANSPORT. THE LEAK ORIGINATED FROM THE COMPONENT AT THE EXHAUST PORT. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. PLASMA BREAKTHROUGH DID NOT OCCUR. THE USE OF THE DEVICE WAS NOT CONTINUED, AND THE CIRCUIT WAS SWITCHED TO A NEW NAUTILUS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068486 ↗
• MalfunctionMay 19, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT CLOT FORMATION OCCURRED WITH THE MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR DURING USE. IT OCCURRED FROM (B)(6). THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043352 ↗
• MalfunctionMay 15, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE, THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR EXPERIENCED A MEMBRANE RUPTURE INSIDE THE DEVICE CASING AND A BREAK IN THE DEVICE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THE PATIENT WAS TREATED POST CORONARY ARTERY BYPASS GRAFT, WAS ON 9-DAYS OF USE WITH THE OXYGENATOR, AND RECEIVING 2 OF SWEEP AND 2.7-3.2 LITERS OF FLOW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026881 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED IN THE MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR PRIOR TO USE. THE DEVICE WAS ON A PRIMED BACKUP CIRCUIT. THE LEAK WAS IDENTIFIED AS ORIGINATING FROM THE COMPONENT. PLASMA BREAKTHROUGH DID NOT OCCURRED. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940879 ↗
• MalfunctionApr 25, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING PRIMING OF THE MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, AN AIR BUBBLE COULD NOT BE REMOVED FROM THE PRE-MEMBRANE SIDE PRIOR TO USE. THE AIR BUBBLE WAS JUMPING AROUND. ADDITIONALLY, WHEN CHALLENGED WITH AN INJECTION OF 20MLS OF AIR AT 5L/MIN WITH THE YELLOW VENT CAP OFF, AIR CAME OUT THE ARTERIAL SIDE INSTEAD OF VENTING OUT THE HYDROPHOBIC MEMBRANE AS EXPECTED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908012 ↗
• MalfunctionMar 4, 2025Crack; Crack

  IT WAS REPORTED THAT PRIOR TO USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, THERE WAS A CRACK IN THE HOUSING OF THE DEVICE. A COMPLETE CRACK/BREAK OCCURRED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512742 ↗
• MalfunctionMar 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT AT AN UNSPECIFIED TIME THIS MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR WAS DAMAGED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502763 ↗
• MalfunctionJan 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE THERE WAS A LEAK IN THE HEAT EXCHANGER OF THE NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) O XYGENATOR DEVICE. AFTER WEANING OFF ECMO, PINK WATER WITH A FEW MICRO CLOTS WAS OBSERVED UPON DRAINING THE WATER LINES. THE LEAK WAS IDENTIFIED AS A ONE-WAY LEAK, NOT REACHING THE PATIENT, AND THERE WERE NO SIGNS OF HEMOLYSIS IN THE PATIENT. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE CUSTOMER DID NOT FEEL THAT IT WAS A WATER TO BLOOD LEAK AND THEREFORE DID NOT GET TO THE PATIENT. THE LOCATION OF THE LEAK WAS SPECIFIED AS THE HEAT EXCHANGER. THE HEATER COOLER WAS REFILLED WITH WATER AND DRAINED AGAIN TO CONFIRM THE SOURCE OF THE LEAK FROM INSIDE THE HEATER COOLER. THE USE OF THE DEVICE WAS NOT CONTINUED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091672 ↗
• MalfunctionDec 5, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF NAUTILUS OXYGENATOR, IT WAS REPORTED THAT AIR WAS NOTED IN THE DEVICE DURING PRIMING. THE AFFECTED CIRCUIT WAS PRIMED IN THE USUAL MANNER WITHOUT PROBLEM. UPON INSPECTION, FLUID WAS NOTICEABLE COMING OUT OF THE BLOOD FLOW PATH AND INTO WHAT IS TYPICALLY A SEALED SPACE. AIR FROM THAT SPACE WAS ABLE TO BE ASPIRATED INTO THE CIRCUIT WITH A 50CC SYRINGE. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECTS. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FLUID WAS ENTERING THE AREA AT THE TOP OF THE INLET WHERE IT SHOULD NOT BE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AS THE CUSTOMER PRIMED, THEY OBSERVED FLUID BETWEEN A GAP AT THE INLET OF THE OXYGENATOR AND ONCE THE FLUID ENTERED THAT GAP, IT LOOKED LIKE AIR AND THERE WAS NO WAY TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852968 ↗
• MalfunctionDec 4, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT IT WAS LEAKING BLOOD OUT OF THE GAS OUT PORT OF THE BASE. IT WAS ASSUMED THAT THERE WAS A PMP FIBER LEAK/BREAK. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843302 ↗
• MalfunctionDec 4, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT AIR REMAINED DURING PRIMING AT THE ARTERIAL OUTLET AND THEN AT THE PURGE OUTLET, EVEN AFTER HOURS OF CIRCULATION. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS PRIMED BY GRAVITY THEN PLACED IN A ROLLER PUMP TO PRESSURE PRIME. THE ROOT CAUSE OF AIR ENTRY WAS DETERMINED TO BE RESIDUAL AIR FROM PRIMING. THERE WAS NO BUBBLE DETECTOR IN THE LINE AS THE DEVICE WAS JUST BEING PRIMED AS A BACK UP OXYGENATOR TO HAVE AVAILABLE FOR FURTHER CUT INS. THE YELLOW VENT CAP WAS REMOVED DURING PRIMING. THE PUMP WAS TURNED OFF AND ON TO TRY AND FIND DIFFERENT WAYS TO REMOVE THE AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842742 ↗
• MalfunctionNov 27, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF NAUTILUS OXYGENATORS, IT WAS REPORTED THAT AIR WAS NOTED IN THE DEVICES DURING P RIMING. THE AFFECTED CIRCUITS WERE PRIMED IN THE USUAL MANNER WITHOUT PROBLEM. UPON INSPECTION, FLUID WAS NOTICEABLE COMING OUT OF THE BLOOD FLOW PATH AND INTO WHAT IS TYPICALLY A SEALED SPACE. AIR FROM THAT SPACE WAS ABLE TO BE ASPIRATED INTO THE CIRCUIT WITH A 50CC SYRINGE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS DEFECT WAS NOTED ON LOT NUMBERS 2409287 AND 2409360 WITH THREE OXYGENATORS. CIRCUITS WERE SUCCESSFULLY PRIMED WITH TWO OXYGENATORS FROM TWO DIFFERENT LOT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798153 ↗