PRISMAFLEX SETS (ST)
Received Jul 8, 2026 · Event occurred May 26, 2026
Report 8010182-2026-00560 · MDR key 25751902
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955468
Lot number
25D0051CA
Product problems
- Air/Gas in Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN AIR LEAK WAS OBSERVED AT THE ARTERIAL CONNECTOR OF A PRISMAFLEX ST100 SET, DESCRIBED AS "PERSISTENT AIR BUBBLES WERE DETECTED". THE TUBING WAS REPLACED TO CONTINUE TREATMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
PRISMAFLEX ST100 SET C HAS BEEN TEMPORARILY APPROVED FOR USE IN THE US UNDER EMERGENCY USE AUTHORIZATION EUA (b)(4) 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.
Remedial action
- Notification