MalfunctionFIP
ULTRAFILTER HECHINGEN
Received Oct 3, 2024 · Event occurred Sep 7, 2024
Report 9611369-2024-00176 · MDR key 20359250
Device
Generic name
Subsystem, Water Purification
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
114604
Lot number
NI
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
52 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 A U9000 ULTRAFILTER LEAKED DURING HEMODIALYSIS THERAPY. THE FILTER WAS REPLACED TO CONTINUE TREATMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.