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

Model Number	DD+ELISIO-H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
15 minutes into hdf dialysis treatment, staff noticed bloodleak in the dialyzer.Machine did not alarm for any issues, only vam (venous acces monitor) alarm was noted.The facility tested for blood leak and results were positive.Prophylactic antibiotics were administed.Per facility, patient has been using the elisio-h dialyzers for the past 4 years.The priming procedures were according to the fresenius machine for online priming.Dialysis setting swere hdf post dilution.Still pending additional information from facility.

• 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: 19106768
• Report Number: 1056186-2024-00004
• Device Sequence Number: 7407774
• Product Code: KDI
• UDI-Device Identifier: 00383790007122
• UDI-Public: 00383790007122
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/15/2024
• Report Date (Section F): 04/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: DD+ELISIO-H
• Device Lot Number: 23G03P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/22/2024
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• 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: 04/15/2024