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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s clinical manager reported that an internal dialyzer blood leak occurred two hours and forty minutes after the initiation of the patient¿s hemodialysis (hd) treatment.It is unknown if the leak was visually observed.The machine, a fresenius 2008t machine alarmed appropriately with a blood leak alarm.A fresenius bloodline was also in use.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 250ml.The patient did not restart treatment and ended one hour and five minutes early.There was no patient serious injury or medical intervention required due to this event.The complaint device was reported to be available to be returned to the manufacturer for evaluation.Three photos have been provided.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 24839693
• Report Number: 3002807005-2026-00033
• Device Sequence Number: 9631118
• Product Code: KDI
• UDI-Device Identifier: 04039361259570
• UDI-Public: 04039361259570
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: F00012970
• Device Lot Number: G8FG26100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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 HEMODIALYSIS MACHINE.
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 102 KG