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	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A nurse reported that there was a dialyzer blood leak during a hemodialysis (hd) treatment.In a follow up, the nurse reported that the blood leak occurred at 3:19 minutes.The nurse explained that the leak was not seen visually.The leak was an internal leak.A blood strip test was used and it tested positive for the presence of blood.The 5008x machine did alarm with a blood leak alarm.The patient¿s estimated blood loss was 200ml.Fresenius blood lines were being used.There was no damage seen on the dialyzer.There was no patient injury, adverse event or medical intervention reported.There was only 18 min left of the treatment, so the patient was not restarted.The device is available to be returned 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; frankfurter str. 6-8; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): St. Wendel AG; 920 winter st; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 25534662
• Report Number: 3002807005-2026-00048
• Device Sequence Number: 9313157
• Product Code: KDI
• UDI-Device Identifier: 04039361259570
• UDI-Public: 04039361259570
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/28/2026

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: G8FF24100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 07/25/2026; 07/28/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 07/28/2026; 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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 5008X MACHINE; FRESENIUS BLOOD LINES
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 134 LB