inforMED
MalfunctionFJI

DIALYZER

Received Feb 1, 1994 · Event occurred Jan 5, 1994

Report MW1000537 · MDR key 11154

Device

Model number

CT 1906

Lot number

C93007X

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.