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
Clinical investigation: a temporal relationship exists between hd therapy utilizing the fx coral fx80 hf dialyzer, and the serious adverse events of two blood leak events, resulting in blood loss and the early termination of treatment.The clinical manager attributed the cause of the serious adverse events to an internal blood leak within the fx coral fx80 hf dialyzer.As stated in the instructions for use, the dialyzer should only be used in conjunction with a blood leak detector and a net fluid removal monitoring system on the hemodialysis device dialyzers may leak resulting in patient blood loss.In the event of a blood leak during dialysis, the health care provider should respond according to the facility¿s established protocol.Based on the information available, the fx coral fx80 hf dialyzer cannot be disassociated from the serious adverse events.While no manufacturing defect or damage was reported during set-up, the serious adverse events did occur during hd therapy while utilizing the fx coral fx80 hf dialyzer.Furthermore, given the blood loss and no manufacturer evaluation/investigation of the fx coral fx80 hf dialyzer, this clinical investigation cannot be excluded from playing causal or contributory role in the serious adverse events.Should additional information become available, the file will be reassessed and the need for a revised clinical investigation will be evaluated.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
On (b)(6) 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 11/mar/20265, 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.
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.
Additional Manufacturer Narrative
Additional information: a1, a4, b5, b7, h10 concomitant products, plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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
Corrected information: d4 lot number.
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) 20265, 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.
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.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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 was not 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: 24649917
• Report Number: 3002807005-2026-00024
• Device Sequence Number: 10168702
• Product Code: KDI
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/26/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 03/25/2026; 05/26/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 03/23/2026; 03/26/2026; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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 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: 233 LB