MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT HEMOFLOW F4 LF 15/CS 0.7SA ETO; DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number	0520161A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/08/2025
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 visible internal dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.Fresenius bloodlines were not in use.The patient¿s estimated blood loss (ebl) was approximately 150ml.There was no patient serious injury or medical intervention required as a result of this event.The patient did not finish the treatment.The complaint sample is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
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.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
Event or Problem Description
A user facility¿s registered nurse (rn) reported that a visible internal dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.Fresenius bloodlines were not in use.The patient¿s estimated blood loss (ebl) was approximately 150ml.There was no patient serious injury or medical intervention required as a result of this event.The patient did not finish the treatment.The complaint sample is not available to be returned to the manufacturer for evaluation.

• Brand Name: HEMOFLOW F4 LF 15/CS 0.7SA ETO
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 23300953
• Report Number: 0001713747-2025-00718
• Device Sequence Number: 4864226
• Product Code: FJI
• UDI-Device Identifier: 00840861100026
• UDI-Public: 00840861100026
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K874872
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 0520161A
• Device Lot Number: 24PU04013
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2024
• 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 HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 23 KG