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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/22/2026
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 user facility's clinic manager (cm) reported that an internal dialyzer blood leak occurred three hours after the initiation of a patient¿s hemodialysis (hd) treatment.The leak was not visually observed.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.There was no defect or damage noted on the dialyzer.Fresenius bloodlines were also in use.The patient's estimated blood loss (ebl) was approximately 300ml.There was no patient serious injury or medical intervention required as a result of this event.The patient did not complete treatment.The patient did not experience any issues due to not completing treatment.The complaint device was returned to the manufacturer for evaluation.
Event or Problem Description
A user facility¿s clinic manager (cm) reported that an internal dialyzer blood leak occurred three hours after the initiation of a patient¿s hemodialysis (hd) treatment.The leak was not visually observed.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.There was no defect or damage noted on the dialyzer.Fresenius bloodlines were also in use.The patient¿s estimated blood loss (ebl) was approximately 300ml.There was no patient serious injury or medical intervention required as a result of this event.The patient did not complete treatment.The patient did not experience any issues due to not completing treatment.The complaint device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.Visual examination and a tightness test of the sample did not confirm the reported failure.A production records review was performed on the reported lot.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.The investigation into the complaint did not confirm the reported event.

• 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: 24201740
• Report Number: 3002807005-2026-00008
• Device Sequence Number: 9635468
• Product Code: KDI
• UDI-Device Identifier: 00840861102648
• UDI-Public: 00840861102648
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/13/2026

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: F00009217
• Device Lot Number: G8FC25100
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 63 KG