MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD NIPRO SURDIAL DX HEMODIALYSIS SYSTEM; HYPODERMIC NEEDLE

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	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reported condition: front rotor panel flat head screw is missing.The national service engineer installed new blood pump rotor assembly serial# (b)(6) and perform blood pump occlusion and adjustment procedure.Machine operates per manufacturer specifications.

• Brand Name: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD; 10/2 moo 8; bangnomko; sena, ayuthaya 13110 ; TH 13110
• 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: 23411278
• Report Number: 3016250252-2025-00016
• Device Sequence Number: 18413262
• Product Code: KDI
• UDI-Device Identifier: 00383790008815
• UDI-Public: 00383790008815
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/28/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• 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