FX CORAL FX80 HF 24/CS 1.8SA STEAM
Received Jul 10, 2026 · Event occurred Jun 29, 2026
Report 3002807005-2026-00054 · MDR key 25780677
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
St. Wendel AgCatalog number
F00012970
Lot number
H8FA12100
Product problems
- Fluid/Blood Leak
Patient
71 YR · Male
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS CORAL DIALYZER LEAKED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.