MAUDE Adverse Event Report: SHIBUYA (SBY) NIPRO SURDIAL DX HEMODIALYSIS SYSTEM; HEMODIALYSIS MACHINE

Model Number	MC+SDX01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reported condition: e74, e75 and e132.Machine not ejecting blood lines cartridge from blood pump rotor.Noise during ejection.The national service engineer tested the blood pump rotor and it failed blood pump occlusion test for being too tight.Rotor assembly complete without any noise under normal operation until attempted ejection.Replaced blood pump rotor assembly.Set proper blood occlusion with feeler gauge and passed blood pump rotor pressure within 5 revolutions.Push pin depth at.72 mm.Passed all tests after replacement.Machine is operating per manufacturers specifications.

• Brand Name: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
• Common Device Name: HEMODIALYSIS MACHINE
• Manufacturer (Section D): SHIBUYA (SBY); 2-72, wakamiya; kanazawa, isikawa 920-0 054; JA 920-0054
• MDR Report Key: 24990021
• Report Number: 1056186-2025-00038
• Device Sequence Number: 9535238
• Product Code: KDI
• UDI-Device Identifier: 00383790008815
• UDI-Public: 00383790008815
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 04/24/2026
• Report Date (Section F): 04/24/2025

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: MC+SDX01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• 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: 04/24/2025