MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO CELLENTIA-H DIALYZER

Model Number	DD+CT17H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported blood leak occurrence as soon as the treatment started, machine alarmed for blood leak right away.No medications were given, no patient symptoms present, no medical intervention required.Blood was not visible, no defect or damage detected on the dialyzer.Blood leak test strip was negative.Treatment interrupted, approximately 200ml of blood loss.New machine was set up with new supplies.Patient completed treatment.Dialysis machine: 2008t, fresenius bloodline used, dialysate flow rate (dfr): autoflow 1.5, blood flow rate (bfr): 300.Gender: male, weight: 93kg, diagnosis: aki (acute kidney injury), patient has been on dialysis 3 times a week since (b)(6) 2025.

• Brand Name: NIPRO CELLENTIA-H DIALYZER
• Common Device Name: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• MDR Report Key: 21985373
• Report Number: 1056186-2025-00012
• Device Sequence Number: 4488202
• Product Code: KDI
• UDI-Device Identifier: 00383790004398
• UDI-Public: 00383790004398
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2025
• Report Date (Section F): 05/06/2025

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 Model Number: DD+CT17H
• Device Lot Number: 24F27E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2025
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male
• Date Report Sent to FDA: 05/06/2025