inforMED
MalfunctionDTZ

FUSION HOLLOW FIBER OXYGENATOR

Received Jul 31, 2026 · Event occurred Jul 29, 2026

Report 2184009-2026-01244 · MDR key 50100594

Device

Generic name

Oxygenator, Cardiopulmonary Bypass

Manufacturer

Perfusion Systems

Model number

BB811

Catalog number

BB811

Lot number

Unknown

Product problems

  • Fluid/Blood Leak
  • Gas Output Problem

Patient

Not reported

  • Hemorrhage/Blood Loss/Bleeding