MalfunctionFIP
ULTRAFILTER HECHINGEN
Received Nov 19, 2025 · Event occurred Oct 13, 2025
Report 9611369-2025-00196 · MDR key 23597763
Device
Generic name
Subsystem, Water Purification
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
NI
Lot number
NI
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
48 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE ULTRAFILTER OF AN AK 98 MACHINE DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
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.