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
• MDR Report Key: 21537629
• Report Number: 1056186-2025-00006
• Device Sequence Number: 12673166
• Product Code: KDI
• UDI-Device Identifier: 00383790007122
• UDI-Public: 00383790007122
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 03/06/2025
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/04/2025
• Device Age: 3 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/06/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/07/2025
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/06/2025