MAUDE Adverse Event Report: SHIBUYA (SBY) NIPRO SURDIAL DX HEMODIALYSIS SYSTEM; DIALYSIS 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	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reported condition: customer reported that screw was missing from rotor.The national service after investigating, identified that 1 of the 2 screws holding the blood pump rotor faceplate was missing.Original blood pump rotor gap and occlusion pressure are within manufacture's specifications.Performed a visual inspection of the blood pump module and only located the missing faceplate screw on the blood pump rotor, no other abnormalities identified.Installed the new blood pump rotor and proceeded with performing the blood pump occlusion calibration to manufacture specifications.Followed up with a simulated treatment to verify proper operation of the device.Adjusted the blood pump speed during testing to ensure the blood pump module was working to manufacture specifications and no issues or alarms identified during testing.Completed a heat citric disinfection after device verification process.Machine has been tested, verified, and disinfected per ifu.Sdx is operating to manufacture specifications and released for patient use.

• Brand Name: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
• Common Device Name: DIALYSIS MACHINE
• Manufacturer (Section D): SHIBUYA (SBY); 2-72, wakamiya; kanazawa, isikawa 920-0 054; JA 920-0054
• Manufacturer (Section G): SHIBUYA (SBY); 2-72, wakamiya; kanazawa, isikawa 920-0 054; JA 920-0054
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 24990340
• Report Number: 3016250252-2025-00018
• Device Sequence Number: 18652886
• Product Code: KDI
• UDI-Device Identifier: 00383790008815
• UDI-Public: 00383790008815
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182940
• 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
• Report Date (Section B): 04/24/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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