MalfunctionFIP
ULTRAFILTER HECHINGEN
Received May 15, 2025 · Event occurred Mar 21, 2025
Report 9611369-2025-00070 · MDR key 22031027
Device
Generic name
Subsystem, Water Purification
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
114604
Lot number
NI
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
36 YR · Female
- 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 A U9000 ULTRAFILTER DURING HEMODIALYSIS THERAPY WITH AN AK 96 MACHINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.