A.M.G. PMP Sterile A.M.G. Module PMP NO T.P. SterileRecalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 08034013782020), received between Nov 15, 2019 and Mar 30, 2026 — classified as 2 deaths, 15 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (53 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT WAS PRIMED AND RAN FOR HOURS. WHEN THEY WERE READY TO GO, A SLUG OF AIR WENT UP INTO THE ART LINE. THE PERFUSIONIST CAUGHT THE AIR BEFORE IT WENT TO THE PATIENT. THE AIR WAS REMOVED AND THE OXYGENATOR WAS EXCHANGED AS THEY COULDN'T RULE OUT AS SOURCE OF AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716941 ↗
• MalfunctionMar 4, 2026Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT THE OXYGENATOR STARTED WHISTLING LIKE THE SOUND OF AIR DURING PRIMING. AS THE FLOW OF THE OXYGENATOR WAS TURNED UP, THE WHISTLING SOUND INCREASED WITHOUT AIR HOOKED UP TO IT. AIR COULD BE FELT COMING FROM THE TOP OF THE OXYGENATOR. THE OXYGENATOR WAS REPLACED WITH A NEW ONE IN CIRCUIT. THE OXYGENATOR WAS INTENDED TO RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508008 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS ADDITIONALLY REPORTED THAT NO ISSUES WERE NOTED DURING PRIMING. NO LEAKING OF CRYSTALLOID WAS NOTED DURING ROUTINE CHECK OF THE PRIMED PUMP. THE PATIENT WAS UNSTABLE AND HAD TO BE OFF OF VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) FOR THE CIRCUIT EXCHANGE BUT TOLERATED IT WELL WITH INCREASED PRESSORS. THE LEAKAGE SEEMED INTERMITTENT; INITIALLY THE SOURCE WAS THOUGHT TO BE FROM A PIGTAIL WHICH WAS CHANGED OUT. THE LEAKAGE WAS FROM THE INSIDE OF THE BLUE PORTION ON THE BOTTOM OF THE OXYGENATOR. THE NEW OXYGENATOR WORKED FINE. NO INFECTIOUS RISK WAS NOTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241502 ↗
• DeathJan 12, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT LIMITED INFORMATION WAS AVAILABLE OTHER THAN THE STORY THAT THE AMG OXYGENATOR CLOTTED WITHIN 30 MINUTES OF INITIATION RESULTING IN LOW FLOWS DESPITE MAX CENTRIMAG'S RPM'S AND HIGH DELTA P'S. THE PERFUSIONIST RECOGNIZED A POSSIBLE OXYGENATOR THROMBUS AND ELECTED TO CHANGE OUT THE OXYGENATOR. IT WAS SAID THE BLOOD FLOW WAS 2.5 LPM, THE RPM WAS 4500, AND THE SWEEP WAS 3. THE OXYGENATOR INLET AND OUTLET PRESSURES AT THE TIME THE ISSUE OCCURRED WERE UNKNOWN. THE INITIATION OF SUPPORT WAS AT 1049, AND THE ISSUE OCCURRED AT 1133. IT WAS SAID THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. THE VALUE OF THE ACT/PTT WAS 144 SECONDS (1011, PRE-ECMO INITIATION), 291 SECONDS (1044, PRE-ECMO INITIATION), AND 259 SECONDS (1125, POST-ECMO INITIATION, PRE-OXYGENATOR EXCHANGE). THE PATIENT WAS TRANSFERRED TO (B)(6) ON (B)(6) 2024 AT 1630 AND WAS SAID TO BE DECEASED AT AN UNKNOWN DATE AND TIME. IT WAS SAID THE PATIENT WAS ADMITTED ON (B)(6) 2024 WHERE THEY EXPERIENCED PHARYNGITIS WITH A DIFFUSE RASH, DEVELOPED FEVER AND PRESENTED TO AN OUTSIDE HOSPITAL WITH SEVERE TROPONIN ELEVATION, DIFFUSE ST ELEVATIONS WITHOUT CHEST PAIN, DIABETIC KETOACIDOSIS (DKA), ACUTE HEART FAILURE, AND

  Patient problems: Insufficient Information

  MAUDE report 24047901 ↗
• MalfunctionDec 28, 2025Infusion or Flow Problem; No Apparent Adverse Event; Infusion or Flow Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND PRESSURES INCREASED WITH FLOWS FALLING WITHIN 1.5 HOURS. CANNULAS WERE MOVED AND ALSO REPLACED FOR LARGER CANNULAS WITH NO INCREASE IN FLOWS. THE OXYGENATOR WAS REPLACED AND FLOWS RETURNED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903685 ↗
• InjuryDec 4, 2025Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  THE VALUE OF THE ACT/PTT WAS 144 SECONDS (1011, PRE-ECMO INITIATION), 291 SECONDS (1044, PRE-ECMO INITIATION), AND 259 SECONDS (1125, POST-ECMO INITIATION, PRE-OXYGENATOR EXCHANGE). THE PATIENT WAS TRANSFERRED TO (B)(6) MEDICAL CENTER (B)(6) ON (B)(6) 2024 AT 1630 AND WAS SAID TO BE DECEASED AT AN UNKNOWN DATE AND TIME. IT WAS SAID THE PATIENT WAS ADMITTED ON (B)(6) 2024 WHERE THEY EXPERIENCED PHARYNGITIS WITH A DIFFUSE RASH, DEVELOPED FEVER AND PRESENTED TO AN OUTSIDE HOSPITAL WITH SEVERE TROPONIN ELEVATION, DIFFUSE ST ELEVATIONS WITHOUT CHEST PAIN, DIABETIC KETOACIDOSIS (DKA), ACUTE HEART FAILURE, AND MULTI-ORGAN FAILURE INCLUDING SHOCK LIVER AND RENAL INSUFFICIENCY, WITH TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWING SEVERE BIVENTRICULAR DYSFUNCTION. ON (B)(6) 2024, IT WAS CONSULTED FOR VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) AND THE CARDIAC SURGERY TEAM AGREED. THE PATIENT WENT DOWN TO THE CATHETERIZATION LAB/HYBRID OR AT 0900 APPROX. THE PATIENT HAD AN IMPELLA CP PLACED LESS THAN AN HOUR PRIOR TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WITH HEPARIN GIVEN IN THE CATHETERIZATION LAB, AND UPON ARRIVAL TO THE HVOR, AN ACT OF 144 WAS RECORDED AT 1011. HEPARIN 5,00

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23722008 ↗
• MalfunctionDec 4, 2025Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  THE VALUE OF THE ACT/PTT WAS 432 SECONDS (1530, POST ECMO INITIATION). THE PATIENT WAS TRANSFERRED TO (B)(6) 2025 AT 2131 TO (B)(6) MEDICAL CENTER (B)(6) AND DISCHARGED ALIVE ON (B)(6) 2025. IT WAS SAID ON (B)(6) 2025, THE PATIENT WAS UNDERGOING AN ELECTROPHYSIOLOGY PROCEDURE. DURING INDUCTION OF ANESTHESIA, THE PATIENT WAS NOTED TO BE IN PULSELESS ELECTRICAL ACTIVITY (PEA). ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) WAS INITIATED, AND THE PATIENT WAS RECEIVING ONGOING CARDIOPULMONARY RESUSCITATION (CPR) AT THE TIME OF THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) INITIATION (ECPR). RETURN OF SPONTANEOUS CIRCULATION (ROSC) HAD NOT BEEN ACHIEVED PRIOR TO INITIATION OF ECMO SUPPORT (1509). AN INITIAL HEPARIN BOLUS OF 10,000 UNITS WAS ADMINISTERED AT 1504, AND ECMO WAS INITIATED AT 1509. AT APPROXIMATELY 1525, THE OXYGENATOR WAS DOCUMENTED AS EXCHANGED DUE TO A CLOT. AN ACT OBTAINED AT 1530 WAS 432 SECONDS. THE EUROSETS AMG PMP ECMO OXYGENATOR WAS EXCHANGED APPROXIMATELY 30 MINUTES INTO THE ECMO RUN FOLLOWING IMPLANTATION DUE TO INABILITY TO MAINTAIN ADEQUATE CIRCUIT FLOW. DECREASED FLOWS THROUGH THE OXYGENATOR RESULTED IN REDUCED ECMO SUPPORT DELIVERED TO THE PATIENT, WHICH AT THAT

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23721919 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE OXYGENATOR STARTED LEAKING WHILE IT WAS BEING PRIMED. A SECOND OXYGENATOR WAS NOTED TO HAVE A CRACK IN THE CONNECTOR. A VIDEO OF THE LEAK AND A PICTURE OF THE CRACK WERE PROVIDED. IT WAS NOTED BY THE REP THAT THIS WAS NOT A CONNECTOR THAT ABBOTT PROVIDED, BUT THE CUSTOMER INSISTED IT WAS. IT WAS CONFIRMED THAT THE CRACKED OXYGENATOR WAS NOT AN ABBOTT PRODUCT. THE REP WAS GOING TO INVESTIGATE THE CONNECTOR IN PERSON. THE OXYGENATOR WAS REMOVED FROM THE CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23685568 ↗
• MalfunctionNov 18, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT AFTER PRIMING THE OXYGENATOR, THERE WAS A HIGH PITCH SOUND NOTED TO BE COMING FROM THE OXYGENATOR WHEN FLOWS WERE ABOVE 2 LITERS PER MINUTE (LPM). THE PUMP SPEED WAS UNKNOWN. FLOWS WERE 2 - 5 LITERS PER MINUTE ON A ROTOFLOW DEVICE. THE SOUND GOT MORE INTENSE AS FLOWS INCREASED. THE OXYGENATOR WAS EXCHANGED. NO ISSUES WERE REPORTED WITH REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585563 ↗
• MalfunctionNov 14, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE WHEN THE NEW CIRCUIT WAS PRIMED, A WHISTLING SOUND WAS HEARD COMING FROM THE OXYGENATOR. THE OXYGENATOR WAS REMOVED FROM THE CIRCUIT AND REPLACED WITH A NEW OXYGENATOR. ALL OTHER COMPONENTS WERE THE SAME. THERE WAS NO WHISTLING SOUND AFTER THE OXYGENATOR WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23561653 ↗
• MalfunctionNov 14, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING PRIMING, A LOUD NOISE WAS NOTED. A RATTLING NOISE WAS INITIALLY REPORTED. THE PUMP WAS MOVED TO TWO NEW SYSTEMS (MOTORS AND CONSOLES). ONE HAD THE SCREW IN LOCK, AND ONE HAD THE SNAP IN LOCK, AND THE NOISE WAS STILL NOTED. THE PUMP WAS EXCHANGED FOR A NEW PUMP AND NOISE STILL PERSISTED. THE WHOLE SYSTEM WAS SWITCHED WITH A NEW ADVANCED MEMBRANE GAS (AMG) OXYGENATOR (OLD OXYGENATOR WAS AN AMG), AND THE NOISE WENT AWAY. IT WAS CONCLUDED THAT THE NOISE, LATER DESCRIBED AS A WHISTLING NOISE, CAME FROM THE OXYGENATOR. NO PATIENT WAS INVOLVED. IT WAS CONFIRMED THAT THE NOISE WAS NOT FROM THE PUMP OR MOTOR. PUMP SPEED WAS 1800-2000RPM AND PRIMING FLUID WAS 220ML FOR OXYGENATOR/2 L HUNG TO PRIME THE WHOLE CIRCUIT. PRESSURES WERE NOT MONITORED ON THEIR CIRCUITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23558843 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION ABOUT PUMP SPEED/FLOW RATE AND INLET/OUTLET PRESSURES WAS NOT AVAILABLE. NO ISSUES WERE NOTED WHEN PRIMING AND RECIRCULATING THE PUMP PRIOR TO INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931077 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE CRACK OCCURRED ABOUT FIVE DAYS INTO THE RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890828 ↗
• MalfunctionJul 7, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE CUSTOMER ORDERED A BOX OF ADULT EUROSET AMG OXYGENATORS AND RECEIVED THEM IN A DAMAGED SHIPPING BOX. THEY REQUESTED THEY BE REPLACED WITH A NEW SHIPMENT. IMAGES WERE PROVIDED. THERE WERE 4 OXYGENATORS IN THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412231 ↗
• MalfunctionJul 7, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE CUSTOMER ORDERED A BOX OF ADULT EUROSET AMG OXYGENATORS AND RECEIVED THEM IN A DAMAGED SHIPPING BOX. THEY REQUESTED THEY BE REPLACED WITH A NEW SHIPMENT. IMAGES WERE PROVIDED. THERE WERE 4 OXYGENATORS IN THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412215 ↗
• MalfunctionJul 7, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE CUSTOMER ORDERED A BOX OF ADULT EUROSET AMG OXYGENATORS AND RECEIVED THEM IN A DAMAGED SHIPPING BOX. THEY REQUESTED THEY BE RELACED WITH A NEW SHIPMENT. IMAGES WERE PROVIDED. THERE WERE 4 OXYGENATORS IN THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412197 ↗
• MalfunctionJul 7, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE CUSTOMER ORDERED A BOX OF ADULT EUROSET AMG OXYGENATORS AND RECEIVED THEM IN A DAMAGED SHIPPING BOX. THEY REQUESTED THEY BE RELACED WITH A NEW SHIPMENT. IMAGES WERE PROVIDED. THERE WERE 4 OXYGENATORS IN THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412195 ↗
• MalfunctionJul 1, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT ONCE THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT WAS PRIMED, A HIGH-PITCHED WHISTLE SOUND CAME FROM THE OXYGENATOR WHEN FLOWS WERE ABOVE 2.0 L/MIN. THE CUSTOMER MADE SURE THE CIRCUIT AND OXYGENATOR WERE FULLY DE-AIRED AND TRIED TO RUN THE PUMP AGAIN BUT HAD THE SAME WHISTLE SOUND. AT THE TIME OF THE ISSUE, THE GAS LINE WAS NOT CONNECTED, AND PRESSURES WERE NOT MEASURED. PUMP FLOW WHEN THE WHISTLING OCCURRED WAS CONSTANT BETWEEN 2.0-5.0 LITERS. THE OXYGENATOR WAS REMOVED FROM THE CIRCUIT AND A SECOND OXYGENATOR WAS USED IN THE CIRCUIT. THE EVENT RESOLVED WITH THE EXCHANGE. THE SECOND OXYGENATOR WAS PRIMED AND USED WITH NO ISSUES. THE CUSTOMER DID NOT RECORD ANY VIDEO OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370997 ↗
• InjuryJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE OXYGENATOR WAS LEAKING ON A PATIENT. THE PERFUSIONIST CUT OUT THE DAMAGED OXYGENATOR AND REPLACED IT WITH A NEW ONE. THE FLOWS AND PRESSURES WERE NOT AVAILABLE. THE FLOWS WERE 2430 RPMS AND 2.71 LPM. A CENTRIMAG PUMP HEAD WAS NOT BEING USED. BLOOD WAS NOTICED ON THE FLOOR AND THE SWEEP WAS TURNED UP AND BLOOD STARTED LEAKING OUT THE BOTTOM. IT SEEMED TO BE COMING FROM THE BLUE PART ON THE BOTTOM BY THE HEAT EXCHANGER. THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR) DURING THE EXCHANGE. THE PATIENT WAS ON SUPPORT FOR 4 DAYS. THERE WERE NO ISSUES NOTED PRIOR TO SUPPORT. THE ACT/PTT WAS UNKNOWN. THE EXCHANGE RESOLVED THE ISSUE. THE PATIENT WAS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 22330023 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS BLOOD EXPELLED FROM THE AMG OXYGENATOR GAS EXHAUST WHEN SIGHING. THIS WAS INITIALLY BLOOD TINGED WATER, HOWEVER OVER TWO DAYS THEN EVOLVED TO RED BLOOD WHEN SIGHING THE OXYGENATOR. THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT WAS THEN EXCHANGED. THE TROUBLESHOOTING THAT WAS PERFORMED WAS HEATER/COOLER (HTP 1500) WAS CHECKED FOR BLOOD. THERE WAS NO VISIBLE BLOOD. WHEN WATER LINES WERE REMOVED THE WATER RAN CLEAR. THE PRE AND POST OXY GASES WERE WITHIN NORMAL LIMITS. SINCE THE PATIENT WAS UNSTABLE THE CHANGEOUT WAS DEFERRED AFTER WEIGH RISKS AND BENEFITS. THERE WERE NO CIRCUIT CONFIGURATIONS OR CUT-INS. ANTICOAGULATION WAS BEING USED. ACTIVATED CLOTTING TIME (ACT) WAS 147. THE SWEEP GAS WAS 4 LPM @100%. THE CHANGE IN PRESSURE WAS 50MMHG. THERE WERE NO MEDICATIONS THROUGH THE OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161800 ↗
• MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS AN OXYGENATOR THAT WAS NOTED TO BE LEAKING THAT WAS ASSESSED DURING THE PRIMING PROCESS. THIS WAS NOT ON A PATIENT. THE OXYGENATOR WAS REMOVED FROM THE CIRCUIT AND NOT USED ON A PATIENT. THIS WAS AN OUT OF BOX FAILURE AND NOT ON A PATIENT. AFTER PRIMING, THE CIRCUIT WAS STORED. DURING CIRCUIT CHECKS THE NEXT DAY IT WAS NOTED THAT FLUID WAS LEAKING FROM THE BOTTOM OF THE OXYGENATOR AND POOLING INSIDE THE PLASTIC CASING. ALL THE CONNECTIONS WERE TIGHT AND SECURE WITH NO OBVIOUS CRACKS AND BROKEN OUTSIDE PLASTIC. THERE WERE NO PHOTOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883769 ↗
• InjuryApr 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT CLOTS ON THE TOP OF THE OXYGENATOR WERE NOTICED ON DAY 2 AND THOSE CLOTS CONTINUED TO GROW. ON DAY 8, THEY ELECTIVELY CHANGED THE OXYGENATOR WITHOUT INCIDENT. THERE WERE NO CHANGES TO ANTICOAGULATION THAT COULD HAVE CONTRIBUTED TO THE EVENT AND NO ADVERSE PATIENT IMPACT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21867846 ↗
• MalfunctionMar 21, 2025Fluid/Blood Leak; Noise, Audible; Fluid/Blood Leak; Noise, Audible

  IT WAS REPORTED THAT DURING PRIMING OF THE OXYGENATOR, THE TEAM NOTICED A WHISTLING NOISE AND A BUILDUP OF CONDENSATION IN THE TOP. THE OXYGENATOR WAS REMOVED AND REPLACED WITH A NEW ONE AND NO FURTHER ISSUES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667704 ↗
• MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE OXYGENATOR CIRCUIT WAS BEING PRIMED ON (B)(6) 2025. LEAKING FLUID WAS NOTICED COMING FROM THE OXYGENATOR ON (B)(6) 2025. THIS WAS NOT ON A PATIENT AND WAS ONLY PRIMED WITH SALINE. A REPLACEMENT OXYGENATOR WAS REQUESTED. A VIDEO WAS PROVIDED AND THE OXYGENATOR WOULD BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596637 ↗
• MalfunctionFeb 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS ADDITIONALLY REPORTED THAT THE PUMP SPEED, PRIMING FLUID FLOW, AND INLET OUTLET PRESSURES AT THE TIME OF THE EVENT WERE UNKNOWN. THE LEAK WAS NOTED IMMEDIATELY DURING THE PRIMING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434946 ↗