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	F00012970
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Discomfort (2330)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, fresenius received a medwatch form 3500a regarding this 71-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 an allergic/hypersensitivity reaction during hd therapy on (b)(6) 2026.The medwatch indicates the patient arrived at the outpatient dialysis clinic for her scheduled hd treatment on (b)(6) 2026.The patient¿s pre-treatment vital signs were as follows :blood pressure (bp = 171/76, pulse = 70, respirations = 19, temperature = 97.6.The patient was reportedly trialing a new type of dialyzer (fx coral fx80 hf dialyzer), and treatment began at 12:39 (b/p = 159/58, pulse = 68).However, after approximately 1-hour and 45 minutes (14:07) into treatment (b/p = 196, pulse = 73) the patient complained of mild generalized itchiness itchy eyes, body, face, back and chest discomfort.The staff documented the presence of angioedema, and the patient was medicated with intravenous push (ivp) benadryl 50 mg, pepcid (dosage, route not provided), and intramuscular (im) solu medrol 125 mg, as well as supplemental oxygen (2 liters).Additionally, the patient¿s treatment was terminated (estimated blood loss = 250 ml), and the extracorporeal blood was not returned.Emergency medical services (ems) were contacted, and the patient was transported to the emergency room for further evaluation.The patient remained alert and oriented throughout the serious adverse events, and her symptoms improved in the er.An electrocardiogram (ekg) was obtained (baseline), a chest x-ray (negative) and the patient¿s elevated troponin level was considered unremarkable given her esrd status.The patient was discharged home and returned for her next scheduled outpatient hd treatment on 25/jul/2026 and tolerated the treatment without incident utilizing a nipro 17h dialyzer.

• 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: 50195016
• Report Number: 3009242923-2026-00007
• Device Sequence Number: 9887273
• Product Code: KDI
• UDI-Device Identifier: 04039361259570
• UDI-Public: 04039361259570
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/10/2026
• Report Date (Section F): 08/10/2026

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: F00012970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/31/2026
• Device Age: MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 112 LB
• Date Report Sent to FDA: 08/10/2026