PRISMAFLEX HF 1000 FILTER SET
Received Dec 8, 2025 · Event occurred Nov 26, 2025
Report MW5180138 · MDR key 23751022
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Baxter Healthcare, S.a.Lot number
25B0085CA
Product problems
- Failure to Power Up
Patient
6 YR · Male
- Hypervolemia
- Hypervolemia
Narrative
Description of Event or Problem
ATTEMPTED TO RESTART CRRT AFTER IT WAS D/C FOR OR PROCEDURE. LOT NUMBER ON FILTER 25B0085CA AND THE UPPER RIGHT OF THE CIRCUIT HAD LIQUID COME INTO THE DE-AIRATION PORTION. CIRCUIT STOPPED AND CLAMPED AND UNABLE TO RESTART SUCCESSFULLY SO D/C AND HL VASCATH UNTIL NEW PRIMING SOLUTIONS SENT FROM PHARMACY. ABLE TO SUCCESSFULLY RESTART CRRT WITH LOT NUMBER 25G0034CA FILTER. PT HAD BEEN OFF OF CRRT FOR AN ADDITIONAL 2 HOURS D/T THE INCIDENT AND HAD BECOME MORE FLUID POSITIVE. SLOWLY WORKED UP TO REMOVE MORE FLUID AS PT TOLERATED.