MalfunctionKPO
401 BICARBY DIALYSATE
Received Jun 8, 2026 · Event occurred Jun 3, 2026
Report MW5189040 · MDR key 25430843
Device
Generic name
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Lot number
26AG06050
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE SETTING UP NEW 401 BICARBY DIALYSATE BAGS FOR CVVH (CONTINUOUS VENO-VENOUS HEMOFILTRATION), ONE STARTED LEAKING. NURSE REMOVED THE LUER-LOCK CAP AND IT STARTED TO LEAK OUT BEFORE CRACKING THE INNER CONE.