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	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomed reports blood pump having an audible clicking sound a couple of weeks ago.The machine was not pulled.January 31st machine was pulled due to blood pump screw falling out and the clinician finished patients' treatment.However, had to manually return the patients blood.2/12/26 field service engineer identified that one of the bolts on the blood pump rotor fell off.New blood pump rotor needed to complete repair.Rotor assy was replaced with a new one under the "blood pump rotor assembly corrective action".Existing blood pump rotor requires replacement.Existing bpr gap is outside specs.(2.9mm).Existing bpr bolts and u-nuts are loose and or missing.Installed new blood pump rotor assembly.Performed blood pump occlusion adjustment procedures.Verified torque mounting screw at 2.94 n-m.Verified start up test complete.Performed a heat citric disinfection.The machine operates per manufacturer's specifications.Performed blood pump rotor assembly arm cover verification.Verified blood pump rotor assembly arm cover, flat head screws, and bpr mounting screw within manufacture specifications.Confirmed start up test complete, without any errors.Performed heat citric disinfection.

• 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: 25073762
• Report Number: 3016250252-2026-00001
• Device Sequence Number: 10402670
• 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): 05/04/2026

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: 04/28/2026
• Initial Report FDA Received Date: 05/04/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown