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

Model Number	BL+A223D/V809D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer advised that the machines are detecting continuous air & blood going into the transducer.No one was injured.The issue occurred during the 1st and 2nd shifts only.After removing the reported lot number, no further issues were noted.The clinic experienced clotted systems and had to restring the machines using bloodlines from a different lot number.All patients were able to complete their treatments without further complications.Some patients did lose blood; however, they are unable to confirm how many patients were affected or the amount of blood lost.They also cannot confirm whether hgb was checked for all patients.

• Brand Name: NIPRO BLOOD TUBING SET W/TP
• 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: 25164933
• Report Number: 8041145-2026-00008
• Device Sequence Number: 18676689
• Product Code: FJK
• UDI-Device Identifier: 00383790004176
• UDI-Public: 00383790004176
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072024
• 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): 05/13/2026

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+A223D/V809D
• Device Lot Number: 25G30-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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