MAUDE Adverse Event Report: ST. WENDEL AG FX CORAL FX80 HF 24/CS 1.8SA STEAM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	F00009217
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 16/jan/2026, fresenius received a product complaint form regarding this 40-year-old female patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a fx coral fx80 hf dialyzer for renal replacement therapy (rrt) reportedly experienced a probable dialyzer reaction during hd therapy on (b)(6) 2026.The patient was reportedly trialing a new type of dialyzer (fx coral fx80 hf dialyzer), however after approximately 10 minutes into treatment the patient complained of mild generalized itchiness (pruritus).The treatment was reportedly halted, and a new extracorporeal circuit was primed utilizing a nipro cellentia 17h dialyzer.Follow-up with the patient¿s hd registered nurse (hdrn) revealed immediately after (initial report stated 10 minutes) the initiation of treatment, the patient reported generalized pruritus.The patient¿s treatment was discontinued without returning the patient¿s extracorporeal blood.The patient¿s estimated blood loss (ebl) was 250 ml, and she was given benadryl 25mg (route not provided) for the pruritus.The patient¿s treatment was restarted and successfully completed on the same hd machine, utilizing a nipro cellentia 17h dialyzer.Per the hdrn, the fx coral fx80 hf dialyzer is not available for return to the manufacturer for evaluation.

• Brand Name: FX CORAL FX80 HF 24/CS 1.8SA 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
• MDR Report Key: 24137030
• Report Number: 3009242923-2026-00002
• Device Sequence Number: 12120058
• Product Code: KDI
• UDI-Device Identifier: 00840861102648
• UDI-Public: 00840861102648
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/21/2026
• Report Date (Section F): 01/21/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: F00009217
• Device Lot Number: F8FM08100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/16/2026
• Device Age: MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 05/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Date Report Sent to FDA: 01/21/2026