MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD NIPRO BLOOD TUBING SET W/TP FOR SURDIALDX HEMODIALYSIS SYSTEM; BLOODLINE

Model Number	BL+A430/V912
Medical Device Problem Code	Inadequate Filtration Process (2308)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Approximately 30 minutes left during treatment patient complained of cramping and nurse gave bolus of saline.While the solution was clear nurse stated she observed a clot in the venous line travel past the clamp box.Stated she clamped the patient line, the clot did not enter the patient.No further intervention needed after clamping the patient blue end of bloodline.Per facility policy the machine was not pulled from service.No additional information provided.Other devices used: surdial dx hemodialysis machine, product code: mc+sdx01, serial# (b)(6).Optilflux dialyzer: unknow code, unknown lot#.

• Brand Name: NIPRO BLOOD TUBING SET W/TP FOR SURDIALDX HEMODIALYSIS SYSTEM
• Common Device Name: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD; 10/2 moo 8; bangnomko; sena, ayuthaya 13110 ; TH 13110
• MDR Report Key: 25145353
• Report Number: 1056186-2025-00039
• Device Sequence Number: 21135426
• Product Code: KDI
• UDI-Device Identifier: 00383790008808
• UDI-Public: 00383790008808
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/11/2026
• Report Date (Section F): 05/11/2026

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: BL+A430/V912
• Device Lot Number: 25D19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/28/2025
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2026
• 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: 05/11/2026