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

Model Number	MC+SDX01
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reported condition: customer reported a clicking noise coming from blood pump area during patient treatment.(b)(6) 2025 national service engineer investigated and was able to duplicate the sound in recirculation with 18g needle and blood pump speed at 400 ml/min.Did not produce noise without the needle restriction.Machine state as found: push pin depth at.62 mm, occlusion test surpassed 14.2 psi in 10 rotations and roller gap passed 2.9 mm test.Cleaned blood pump rotor housing, ensured blood pump motor screws were tightened to specification.Replaced blood pump rotor.Noise persists.Further investigation required.Not cleared for patient use.(b)(6) 2025 national service engineer duplicated noise after more than an hour of running the blood pump at 450 ml/min.Previous replacement of the blood pump rotor demonstrated no change in symptom.Replaced entire tubing pump assembly.Post-replacement calibrations were: roller gap at 2.9 mm; occlusion test surpassed 14.2 psi in less than 5 revolutions; push pin gap was.71 mm.After running for an hour at 450 ml/min, sound was no longer present.Passed all tests.

• 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: 24999420
• Report Number: 3016250252-2025-00019
• Device Sequence Number: 9756397
• Product Code: KDI
• UDI-Device Identifier: 00383790008815
• UDI-Public: 00383790008815
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 04/27/2026

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: 10/31/2025
• Initial Report FDA Received Date: 04/27/2026
• 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