MalfunctionFPB
PALL POSIDYNE® NEO FILTER
Received Feb 24, 2023 · Event occurred Jan 15, 2023
Report 16435225 · MDR key 16435225
Device
Generic name
Filter, Infusion Line
Manufacturer
Pall CorporationModel number
NEO96Catalog number
NEO96
Lot number
22-564
Product problems
- Fluid/Blood Leak
Patient
270 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
TWO INSTANCES OF THE A CARDIAC FILTER TO BE LEAKING. FILTER WAS REMOVED FROM LINE IN EACH INSTANCE.