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

Model Number	DD+CT17H
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has been dialyzing with the use of nipro cellentia 17h dialyzer as prescribed since approximately (b)(6) 2025.Patient complained of severe itching on (b)(6) 2025, patient was administered benadryl 50 mg ivp.Nipro cellentia 17h discontinued and added as an allergy.Additional information received 02/25/2026: the patient was using an 180nre optiflux dialyzer on (b)(6) 2025.The dialyzer was changed to optiflux 180nr on (b)(6) 2026.Then the patient was changed again, to the cellentia 17h on (b)(6) 2025 (no rationale provided).The affected lot number is 25d21e.Benadryl, both oral and iv, was prescribed and administered during the treatment, but it did not resolve the itching.The patient reported severe itching approximately 40 to 60 minutes into treatment, which continued even after the patient returned home.The itching subsided the following day when the patient did not receive treatment.The patient arrived at the clinic without any visible signs or symptoms of itching.

• 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
• Manufacturer (Section G): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi; niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 25383716
• Report Number: 9610987-2026-00041
• Device Sequence Number: 8726255
• Product Code: KDI
• UDI-Device Identifier: 00383790004398
• UDI-Public: 00383790004398
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DD+CT17H
• Device Lot Number: 25D21E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown