A.M.G.PMP PEDIATRIC A.M.G.PMP PEDIATRIC STERILERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08052705493351), received between Feb 18, 2025 and Apr 8, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHILE PRIMING, OXYGENATOR WAS NOTICED THAT THE TOP WAS FILLING WITH WATER AND THE OXYGEN PORT WAS BREACHING. THIS WAS A PEDIATRIC OXYGENATOR, AND THIS HAPPENED DURING THE BLOOD PRIME. NO BLOOD LEAK WAS NOTED. THE OXYGENATOR WAS EXCHANGED. AFTER FURTHER INFORMATION, POSSIBLE BLOOD LEAK WITH WATER WAS ALSO CONCERN. THEY HAD TO CHANGE THE COMPLETE CIRCUIT CONCERNED FOR BLOOD CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821511 ↗
• InjuryDec 23, 2025Fluid/Blood Leak; Mechanical Problem; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Mechanical Problem; Improper or Incorrect Procedure or Method

  THE BLOOD FLOW AND GAS FLOW RATE WAS UNKNOWN. THE OXYGENATOR INLET AND OUTLET PRESSURES AT THE TIME THE ISSUE OCCURRED WAS UNKNOWN SINCE IT WAS NOT MONITORED. THE ISSUE OCCURRED AT AN UNKNOWN MOMENT AFTER INITIATION OF SUPPORT. IT WAS UNKNOWN IF THE DEVICE WOULD BE RETURNING FOR EVALUATION. THE PUMP MOTOR SPEED (RPM) WAS UNKNOWN. THE ACT/PTT WAS UNKNOWN STATUS POST THE ROSS PROCEDURE. THERE WERE NO ISSUES DURING PRIMING OF THE OXYGENATOR PRIOR TO SUPPORT. THE SOURCE OF THE LEAK WAS UNKNOWN. NO BLOOD WAS DRIPPING FROM THE OXYGENATOR. NO PHOTOS OR VIDEOS OF THE LEAK/DRIP WERE AVAILABLE. NO PHOTOS OF THE THROMBUS/CLOT WERE AVAILABLE. IT WAS CONFIRMED WITH THE CHIEF PERFUSION WHO ADDED THE ATTACHED EMAIL WITH FURTHER INFORMATION. AFTER A PHONE CALL WITH THE PERFUSIONIST, FOR WHAT IT IS WORTH, THE CHIEF PERFUSIONIST DID NOT DETERMINE THE OXYGENATOR TO BE OF FAULT. THIS SEEMED LIKE A USER ERROR OR LACK OF EDUCATION AND INEXPERIENCE AND WAS AN UNNECESSARY CHANGE OUT.

  Patient problems: Embolism/Embolus

  MAUDE report 23881925 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN OXYGENATOR WAS RETURNED FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22361915 ↗
• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE OXYGENATOR BEGAN LEAKING BLOOD AFTER TWO DAYS. WHOLE RED BLOOD IN THE GAS OUTLET PHASE OF THE LOWER PORTION OF THE OXYGENATOR WAS NOTED. THERE WAS NO INCREASE IN PRESSURE NOTED AND NO DECREASE IN GAS TRANSFER. THE PUMP SPEED AND BLOOD FLOW RATE WAS 2850 RPMS AND 1.28 LPM. THE BLOOD INLET PRESSURE WAS 200MMHG AND THE BLOOD OUTLET PRESSURE WAS 176MMHG. THE ACTIVATED CLOTTING TIME/PARTIAL THROMBOPLASTIN TIME (ACT/PTT) WAS 70.8. THE PATIENT WAS ON SUPPORT AND STABLE WHEN THEY ELECTED TO CHANGE THE OXYGENATOR FOR A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700652 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE AFTER PRIMING THE AMG PMP OXYGENATOR AND INSTITUTING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THE ICU STAFF NOTICED A LARGE AMOUNT OF DILUTED BLOODY FLUID IN THE LOWER CHAMBER OF THE AMG BELOW THE FIBER BUNDLE. THE STAFF IMMEDIATELY CHANGED THE OXYGENATOR UNDER CONTROLLED CIRCUMSTANCES AND DID NOT RELATE ANY ISSUES OR SEQUALAE TO THE PATIENT. THE SITE NOTED THAT THE PUMP SPEED WAS 3900 ROTATIONS PER MINUTE (RPM), BLOOD FLOW WAS 1.6 LITERS PER MINUTE, INLET PRESSURE WAS 280 MILLIMETERS OF MERCURY (MMHG), AND OUTLET PRESSURE WAS 246 MMHG. THE PARTIAL THROMBOPLASTIN TIME (PTT) WAS 69.2. NO ISSUES WERE REPORTED DURING THE PRIMING OF THE OXYGENATOR. THE ISSUE OCCURRED APPROXIMATELY 22 HOURS AFTER INITIATION OF SUPPORT. THE DEVICE WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392365 ↗