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

Model Number	DD+ELISIO-15H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the beginning of treatment, machine alarmed for blood leak.Blood leak confirmed with positive blood leak strip.Per facility policies and procedures, they were unable to return the patient's blood (approximately 200-250ml of blood in extracorporeal system).Patient was placed on a new extracorporeal system to complete treatment.No intervention necessary.No samples available, no additional information provided.

• 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: 20914244
• Report Number: 1056186-2024-00028
• Device Sequence Number: 7824351
• Product Code: KDI
• UDI-Device Identifier: 00383790007108
• UDI-Public: 00383790007108
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/12/2024
• Report Date (Section F): 12/12/2024

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
• Device Model Number: DD+ELISIO-15H
• Device Lot Number: 24D08H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2024
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• 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: 12/12/2024