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	11/14/2025
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 during a patient¿s hemodialysis (hd) treatment.The patient¿s estimated blood loss (ebl) is unknown.It is unknown if the complaint device is available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the gross visual examination of the sample and the tightness test, no defects or irregularities were visually observed.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.The products were inspected according to the inspection protocol and were found conforming to specifications.The investigation into the complaint was not able to confirm the reported event.
Event or Problem Description
A user facility¿s clinic manager (cm) reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The patient¿s estimated blood loss (ebl) is unknown.It is unknown if the complaint device is available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.

• 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: 23618268
• Report Number: 3002807005-2025-00082
• Device Sequence Number: 15716383
• 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): 01/16/2026

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: G8FC27100
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/10/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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
• Patient Sex: Unknown