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
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD; 10/2 moo 8; bangnomko; sena, ayuthaya 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 25145410
• Report Number: 8041145-2025-00013
• Device Sequence Number: 9396492
• Product Code: KDI
• UDI-Device Identifier: 00383790008808
• UDI-Public: 00383790008808
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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