MAUDE Adverse Event Report: St. Wendel AG FX CORAL FX60 HF 24/CS 1.4SA STEAM; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	F00012969
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cyanosis (1798); Hemorrhage/Blood Loss/Bleeding (1888); Numbness (2415)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury

• Brand Name: FX CORAL FX60 HF 24/CS 1.4SA STEAM
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): St. Wendel AG; st. wendel plant; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): St. Wendel AG; st. wendel plant; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 50855629
• Report Number: 3002807005-2026-00082
• Device Sequence Number: 9936116
• Product Code: KDI
• UDI-Device Identifier: 04039361259150
• UDI-Public: 04039361259150
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K243874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: F00012969
• Device Lot Number: G9FM11100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 178 LB