ULTRAFILTER HECHINGEN
Received Sep 6, 2024 · Event occurred Jun 18, 2024
Report 9611369-2024-00156 · MDR key 20157771
Device
Generic name
Subsystem, Water Purification
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
UNK_PRD_00349
Lot number
NI
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
68 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 DURING HEMODIALYSIS THERAPY WITH AN AK 98 MACHINE EQUIPPED WITH A U900 ULTRAFILTER. 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.