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

Model Number	DD+ELISIO-19H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
1.5 hours into dialysis treatment, machine alarmed for blood leak.Treatment was interrupted and patient was moved to a different machine/set-up.Approximately 250ml of blood loss.The test strip we used was positive and no blood was visible in the affluent dialysate.We had no other blood leaks with this lot number.Zofran was administered to the patient.There were no medical interventions, however patient did require dialysis access revision the following day.Dialysis settings: bfr 350, dfr 600.
Event or Problem Description
1.5 hours into dialysis treatment, machine alarmed for blood leak.Treatment was interrupted and patient was moved to a different machine/set-up.Approximately 250ml of blood loss.The test strip we used was positive and no blood was visible in the affluent dialysate.We had no other blood leaks with this lot number.Zofran was administered to the patient.There were no medical interventions, however patient did require dialysis access revision the following day.Dialysis settings: bfr 350, dfr 600.
Additional Manufacturer Narrative
3/7/25: this follow up submission is to correct the date of the report on section b4, from 2/4/2025 to 3/6/2025.

• Brand Name: NIPRO ELISIO-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: 21537850
• Report Number: 9610987-2025-00001
• Device Sequence Number: 8050362
• Product Code: KDI
• UDI-Device Identifier: 00383790007122
• UDI-Public: 00383790007122
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K131935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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+ELISIO-19H
• Device Lot Number: 23K02P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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
• Patient Sex: Unknown