A.M.G. PP Sterile A.M.G. MODULE PP NO T.TP.STER.Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08052705496253), received between Jun 13, 2023 and Aug 2, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NOT HARMED. THE REPLACEMENT OXYGENATOR WORKED WELL. THE PUMP SPEED WAS 2400 RPM, THE FLOW WAS 0.8 L/MIN, AND THE GAS FLOW WAS 0.5 L/MIN. THERE WAS A DIALYSIS FILTER BETWEEN THE PUMP AND THE OXYGENATOR. THE ACTIVATED CLOTTING TIME (ACT) WAS APPROXIMATELY 200. AFTER A COUPLE OF HOURS OF SUPPORT, THE PATIENT STARTED TO WAKE UP AND COUGH, AND THE INTENSIVE CARE NURSE NOTICED BLOOD DRIPPING FROM THE BOTTOM OF THE OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19893678 ↗
• MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CENTER HAD AN OUT OF BOX FAILURE ON AN OXYGENATOR. THE OXYGENATOR WAS LEAKING. THERE WAS NO VISIBLE DAMAGE REPORTED TO THE BOX OR THE OXYGENATOR. IT WAS REMOVED FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119843 ↗