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	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A technician reported a dialyzer blood leak during auto-sub plus treatment hemodiafiltration (hdf).In a follow up,a nurse said fx coral fx80 hf 24/cs 1.8sa steam was used for treatment and a blood leak occurred.It is unknown how long into treatment the blood leak occurred during patient¿s hemodialysis (hd) treatment.Confirmed that the machine, a fresenius 5008x machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The leak was visually observed at the arterial end of the dialyzer.It was confirmed that the leak was coming from the dialyzer and not the bloodlines.Stated that fresenius bloodlines were used for treatment, however, bloodline information was unknown.Confirmed that the leak was internal.Stated that there was no defect or damage seen on the dialyzer.Stated that the patient¿s estimated blood loss (ebl) was approximately 300-400 ml.Confirmed that there was no patient injury or medical intervention required as a result of the reported event.The patient was restarted on a new machine and treatment completed successfully with new supplies.
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; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 25038062
• Report Number: 3002807005-2026-00039
• Device Sequence Number: 9726026
• Product Code: KDI
• UDI-Device Identifier: 04039361259570
• UDI-Public: 4039361259570
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2026

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: G8FK08100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 06/10/2026; 06/26/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/14/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2026
• 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: 5008X BLOODLINES.; FRESENIUS 5008X CARESYSTEM.
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 63 KG