ULTRAFILTER HECHINGEN
Received Feb 28, 2025 · Event occurred Jan 20, 2025
Report 9611369-2025-00017 · MDR key 21496032
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
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS: (B)(6). 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 98 MACHINE. A "LARGE POOL OF WATER" WAS AT THE BASE ON THE MACHINE. THE MACHINE WAS REPLACED TO CONTINUE THERAPY. DURING ONE AND A HALF (1.5) HOURS OF TREATMENT, 2400ML OUT OF 3000ML OF FLUID HAD BEEN REMOVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION PROVIDED.