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	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ni.
Event or Problem Description
On 11/mar/2026, fresenius received a product complaint form regarding this patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a fx coral fx80 hf dialyzer for renal replacement therapy (rrt) reportedly experienced two blood leak events on (b)(6) 2026.The product complaint form (completed by the clinical manager) revealed an internal dialyzer blood leak occurred approximately 1.5 hours into the patient¿s hd treatment.The patient was dialyzed on a fresenius 5008x hemodialysis system, which reportedly alarmed appropriately when the initial blood leak occurred.The patient¿s blood was not returned, resulting in an estimated blood loss (ebl) of approximately 300 ml.The patient¿s treatment was restarted on a separate fresenius 5008x hemodialysis system, utilizing new supplies.Approximately 30 minutes after the initiation of the second treatment, another internal dialyzer blood leak occurred (separate lot number).Again, the fresenius 5008x hemodialysis system alarmed appropriately, and the patient had an additional ebl of approximately 300 ml (total ebl = 600 ml).The patient did not complete treatment on (b)(6) 2026, missing a total of 3.75 hours of treatment.There was no medical intervention required; however, the patient did require an additional treatment the following day.The complaint devices were reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: a2, a4, b5, b7.
Event or Problem Description
On 11/mar/2026, fresenius received a product complaint form regarding this 52-year-old male patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a fx coral fx80 hf dialyzer for renal replacement therapy (rrt) since 2021, that reportedly experienced two blood leak events on (b)(6) 2026.The product complaint form (completed by the clinical manager) revealed an internal dialyzer blood leak occurred approximately 1.5 hours into the patient¿s hd treatment (9:00 am).The patient was dialyzed on a fresenius 5008x hemodialysis system, which reportedly alarmed appropriately when the initial blood leak occurred (verified via blood leak test strip).The patient¿s blood was not returned, resulting in an estimated blood loss (ebl) of approximately 300 ml.The patient¿s treatment was restarted on a separate fresenius 5008x hemodialysis system, utilizing new supplies.Approximately 30 minutes after the initiation of the second treatment, another internal dialyzer blood leak occurred (separate lot number).Again, the fresenius 5008x hemodialysis system alarmed appropriately (verified via blood leak test strip), and the patient had an additional ebl of approximately 300 ml (total ebl = 600 ml).The patient did not complete treatment on (b)(6) 2026, missing a total of 3.75 hours of treatment.Although no medical intervention was required, post event hematological studies revealed the patient¿s hemoglobin dropped (result not provided) following the blood loss event.However, the patient was asymptomatic and did not require any medical intervention beyond undergoing an abbreviated hd treatment on (b)(6) 2026 to remove fluid.It should be noted that no visible damage was noted on either dialyzer.
Event or Problem Description
On 11/mar/2026, fresenius received a product complaint form regarding this patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a fx coral fx80 hf dialyzer for renal replacement therapy (rrt) reportedly experienced two blood leak events on (b)(6) 2026.The product complaint form (completed by the clinical manager) revealed an internal dialyzer blood leak occurred approximately 1.5 hours into the patient¿s hd treatment.The patient was dialyzed on a fresenius 5008x hemodialysis system, which reportedly alarmed appropriately when the initial blood leak occurred.The patient¿s blood was not returned, resulting in an estimated blood loss (ebl) of approximately 300 ml.The patient¿s treatment was restarted on a separate fresenius 5008x hemodialysis system, utilizing new supplies.Approximately 30 minutes after the initiation of the second treatment, another internal dialyzer blood leak occurred (separate lot number).Again, the fresenius 5008x hemodialysis system alarmed appropriately, and the patient had an additional ebl of approximately 300 ml (total ebl = 600 ml).The patient did not complete treatment on (b)(6) 2026, missing a total of 3.75 hours of treatment.There was no medical intervention required; however, the patient did require an additional treatment the following day.The complaint devices were reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Correction: the d4 lot number has been corrected.

• 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
• MDR Report Key: 24650558
• Report Number: 3009242923-2026-00004
• Device Sequence Number: 21372384
• Product Code: KDI
• UDI-Device Identifier: 04039361259570
• UDI-Public: 04039361259570
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026
• Report Date (Section F): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: F00012970
• Device Lot Number: G8FG23100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/11/2026
• Device Age: MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/20/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/23/2026; 03/25/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 03/24/2026; 03/26/2026
• Date Device Manufactured: 12/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Date Report Sent to FDA: 03/20/2026