MalfunctionKDI
PRISMAFLEX SETS (M)
Received Jul 15, 2026 · Event occurred Jun 15, 2026
Report 8010182-2026-00577 · MDR key 25829485
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955595
Lot number
25H0019CB
Product problems
- Fluid/Blood Leak
- Loose or Intermittent Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE RETURN LUER CONNECTOR OF A PRISMAFLEX M100 SET COULD NOT BE SECURELY FASTENED AND RESULTED IN AN EXTERNAL FLUID LEAK 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