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	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/04/2026
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 registered nurse (rn) reported that a fresenius coral dialyzer did not clear air during priming resulting in an ¿air detector¿ alarm on the machine during a patient¿s hemodialysis (hd) treatment and subsequent blood loss.Upon follow up, the rn said that immediately after the initiation of the patient¿s hemodialysis (hd) treatment a fresenius 2008t machine displayed an air detector alarm.It was determined at that time that the dialyzer had clotted.A fresenius bloodline was in use.The patient¿s estimated blood loss (ebl) was approximately 300ml.It is unknown how many units of heparin were in use.It is unknown how much prime solution was used.The dialyzer was rotated and tapped during priming.The patient was restarted on a new machine and treatment completed successfully with new supplies.There was no patient serious injury or medical intervention required as a result of this event.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility's registered nurse (rn) reported that a fresenius coral dialyzer did not clear air during priming resulting in an "air detector" alarm on the machine during a patient¿s hemodialysis (hd) treatment and subsequent blood loss.Upon follow up, the rn said that immediately after the initiation of the patient¿s hemodialysis (hd) treatment a fresenius 2008t machine displayed an air detector alarm.It was determined at that time that the dialyzer had clotted.A fresenius bloodline was in use.The patient¿s estimated blood loss (ebl) was approximately 300 ml.It is unknown how many units of heparin were in use.It is unknown how much prime solution was used.The dialyzer was rotated and tapped during priming.The patient was restarted on a new machine and treatment completed successfully with new supplies.There was no patient serious injury or medical intervention required as a result of this event.The complaint device was reported to be available to be 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 confirmed the reported failure due clotting in the closed fibers.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, nonconformance, 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 was able to 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: 24575234
• Report Number: 3002807005-2026-00021
• Device Sequence Number: 16050227
• Product Code: KDI
• UDI-Device Identifier: 04039361259570
• UDI-Public: 04039361259570
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/30/2026

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: G8FF30100
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 67 KG