PRISMAFLEX SETS (M)
Received Jul 13, 2026 · Event occurred Jun 22, 2026
Report 8010182-2026-00567 · MDR key 25798094
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955595
Lot number
25B0046
Product problems
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX M100 SET, DESCRIBED AS "THE FLOW PROBLEM WAS THAT THE UPPER PUMP HEAD WAS STUCK IN THE PIPE, CAUSING BACKFLOW OF LIQUID AT THE BOTTOM". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Remedial action
- Notification