MalfunctionFJI
DIALYZER
Received Feb 1, 1994 · Event occurred Jan 5, 1994
Report MW1000537 · MDR key 11154
Device
Product problems
- Material Discolored
Patient
80 YR
Narrative
Description of Event or Problem
PT'S DIALYZER WAS BEING PREPARED FOR HIS TREATMENT. DURING THE 15 MIN RECIRCULATION PROCESS TO ULTRAFILTER REPROCESSING SOLUTION OUT IT WAS NOTED THAT THE DIALYZER AND THE NS PRIMED BLOODLINES WERE A DISTINCT GRAY COLOR. THEY WERE REMOVED FROM THE MACHINE AND HELD FOR PICK-UP. THIS WAS REUSE #15; SEMI-AUTOMATED REUSE MACHINE WITH 3.5% DISINFECTANT LOT #3W258, PRETREATMENT WATER MULTIMEDIA TANK, CARBON TANK, SUBMICRON FILTER PRE REUSE NS LOT # UNAVAILABLE.