MAUDE Adverse Event Report: St. Wendel AG FX CORAL FX100 HF 24/CS 2.2SA STEAM; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	F00012971
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported a positive membrane leak using a coral dialyzer on the 5008x machine.In a follow up, the reporter said the leak occurred about 3 hours after the start of the hemodialysis (hd) treatment.The leak was seen internal within the system.Blood tests strips were used and tested positive for the presence of blood.The leak was an internal leak.The 5008x machine did alarm with a blood leak alarm.Fresenius bloodlines were being used.There was no damage noted on the dialyzer.There was patient blood loss of 250 to 300ml.There was no patient injury, adverse event or medical intervention reported beyond the reported patient blood loss.The patient did not complete treatment.The device is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: FX CORAL FX100 HF 24/CS 2.2SA 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 ; +1(617)417-5172
• MDR Report Key: 50884964
• Report Number: 3002807005-2026-00085
• Device Sequence Number: 18817597
• Product Code: KDI
• UDI-Device Identifier: 04039361259594
• UDI-Public: 04039361259594
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 09/24/2026

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: F00012971
• Device Lot Number: G6FH07100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• 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 Machine; Fresenius Bloodlines
• Patient Sex: Female
• Patient Weight: 140 LB