PRISMAFLEX SETS (ST)
Received Jul 8, 2026 · Event occurred Jun 16, 2026
Report 8010182-2026-00555 · MDR key 25749331
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955468
Lot number
25J0053CB
Product problems
- Fluid/Blood Leak
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRISMAFLEX ST100 SET C HAS BEEN TEMPORARILY APPROVED FOR USE IN THE US UNDER EMERGENCY USE AUTHORIZATION EUA200704 TO DELIVER CRRT TO TREAT PATIENTS IN AN ACUTE CARE ENVIRONMENT DURING THE COVID-19 PANDEMIC. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE DEAERATION CHAMBER OF A PRISMAFLEX ST100 SET WAS OBSERVED TO BE CRACKED AND LEAKED DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Remedial action
- Notification