ULTRAFILTER HECHINGEN
Received Sep 10, 2025 · Event occurred May 13, 2025
Report 9611369-2025-00140 · MDR key 23015511
Device
Generic name
Subsystem, Water Purification
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
UNK_PRD_00349
Lot number
NI
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
62 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN ULTRAFILTER U9000 DURING HEMODIALYSIS THERAPY WITH AN AK 98 MACHINE. THERAPY WAS STOPPED AND THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.