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	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
In a follow up for a received/used dialyzer, the nurse reported there was a dialyzer blood leak during a hemodialysis (hd) treatment.The nurse stated that an fx coral fx80 hf 24/cs 1.8sa steam was used for treatment and a blood leak occurred.The blood leak occurred 3hours into the patient¿s hemodialysis (hd) treatment.The nurse 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 not visually observed.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 275 ml.Confirmed that there was no patient injury or medical intervention required as a result of the reported event.The patient¿s treatment was considered completed and patient was not restarted.Stated that the dialyzer was available and has already been returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
In a follow up for a received/used dialyzer, the nurse reported there was a dialyzer blood leak during a hemodialysis (hd) treatment.The nurse stated that an fx coral fx80 hf 24/cs 1.8sa steam was used for treatment and a blood leak occurred.The blood leak occurred 3hours into the patient¿s hemodialysis (hd) treatment.The nurse 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 not visually observed.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 275 ml.Confirmed that there was no patient injury or medical intervention required as a result of the reported event.The patient's treatment was considered completed and patient was not restarted.Stated that the dialyzer was available and has already been returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3.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.

• 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: 25050409
• Report Number: 3002807005-2026-00040
• Device Sequence Number: 10457611
• Product Code: KDI
• UDI-Device Identifier: 04039361259570
• UDI-Public: 04039361259570
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; 5008X BLOODLINES; FRESENIUS 5008X CARESYSTEM; FRESENIUS 5008X CARESYSTEM
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 71 KG