MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH FX CORAL FX60 HF 24/CS 1.4SA STEAM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	F00009216
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s clinical manager (cm) reported that an internal dialyzer blood leak with ten minutes remaining in a patient¿s hemodialysis (hd) treatment.The leak was not visually observed.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were also in use.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 250ml.There was no patient serious injury or medical intervention required as a result of this event.The patient chose not to complete treatment.The complaint device was reported to be 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. .
Event or Problem Description
A user facility¿s clinical manager (cm) reported that an internal dialyzer blood leak with ten minutes remaining in a patient¿s hemodialysis (hd) treatment.The leak was not visually observed.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were also in use.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 250ml.There was no patient serious injury or medical intervention required as a result of this event.The patient chose not to complete treatment.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.No issues were found that could be associated with the reported event.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

• Brand Name: FX CORAL FX60 HF 24/CS 1.4SA STEAM
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 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: 22096649
• Report Number: 3002807005-2025-00037
• Device Sequence Number: 8022670
• Product Code: KDI
• UDI-Device Identifier: 00840861102631
• UDI-Public: 00840861102631
• 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): 07/28/2025

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: F00009216
• Device Lot Number: F9FC19100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2024
• 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 DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 60 KG