BICARBY DIALYSATE RFP-401
Received Apr 23, 2026 · Event occurred Apr 19, 2026
Report MW5187240 · MDR key 24969976
Device
Generic name
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Lot number
25SG06038
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DIALYSATE BAGS FOR CRRT (CRRT DIALYSATE RFP-401 INFUSION) BREAK WHEN ATTEMPTING TO HANG NEW BAGS. AT THE CONNECTOR WHERE YOU HAVE TO BREAK THE SEAL, THE WHOLE PIECE FALLS OUT INSTEAD OF JUST BREAKING. FALANGE ON CRRT DIALYSATE BAGS BREAKING OFF COMPLETELY WHEN SPIKING BAGS. LOT 26AG06016 DIALYSATE BAG FOR CRRT CRACKED/BROKE OPEN ON SIDE SEAM OF BAG WHEN RECONSTITUTING/MIXING CHAMBERS RESULTING IN WASTED MEDICATION/SUPPLY D/T CONTAMINATION RISK FROM DEFECTIVE MEDICATION PACKAGING BICARBY DIALYSATE RFP 401 FRESENIUS MEDICAL REF #RFP-401- G LOT #25SG06037 CRRT DIALYSATE BAG LUER CONNECTION CAME APART WHILE CHECKING CRRT SETUP.RFP-401 MANUFACTURER FRESENIUS; REF # RFP-401-G, LOT #25SG06038. PT: 4582. DEVICE: 1069. REF: MW5187241, MW5187242.