MalfunctionDTZ
Affinity Pixie Pediatric Hollow Fiber Oxygenator
Received Jul 30, 2026 · Event occurred Mar 21, 2023
Report 2184009-2026-01188 · MDR key 50080541
Device
Generic name
Oxygenator, Cardiopulmonary Bypass
Manufacturer
Perfusion SystemsModel number
BBP211Catalog number
BBP211
Lot number
224619961
Product problems
- Fluid/Blood Leak
- Air/Gas in Device
Patient
Unknown
- Hemorrhage/Blood Loss/Bleeding