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 Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); 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.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Based on the information available, the fx coral fx80 hf dialyzer cannot be disassociated from the serious adverse events.While no manufacturing defect or damage was reported, the serious adverse events did occur during hd therapy while utilizing the fx coral fx80 hf dialyzer.Furthermore, given the patient¿s symptoms were indicative of an allergic reaction and the patient¿s favorable responses to benadryl and an alternative dialyzer (nipro cellentia 17h dialyzer), the fx coral fx80 hf dialyzer cannot be excluded from having caused or contributed to serious adverse events.
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
• 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 ; 6174175172
• MDR Report Key: 24132670
• Report Number: 3002807005-2026-00006
• Device Sequence Number: 20197958
• Product Code: KDI
• UDI-Device Identifier: 00840861102648
• UDI-Public: 00840861102648
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 107 KG