inforMED
MalfunctionDTZ

AFFINITY NT BALANCE

Received Jul 29, 2026 · Event occurred Oct 28, 2024

Report 2184009-2026-01178 · MDR key 50072303

Device

Generic name

Oxygenator, Cardiopulmonary Bypass

Manufacturer

Perfusion Systems

Model number

511B

Catalog number

511B

Lot number

UNKNOWN

Product problems

  • Increase in Pressure

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions