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

Model Number	BL+A430/V912
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was previously submitted with the incorrect manufacturer registration number.
Event or Problem Description
During dialysis treatment, machine alarmed instantly for blood leak within the dialyzer, visible in the arterial coupler tubing.Patient was removed from the machine without returning the patient's blood (approximately 250ml of blood loss).Per charge nurse, patient required no follow up or transfusion post incident.Dialyzer used: f250 dialyzer.Machine: surdial dx hemodialysis system."product" code: mc+sdx01.510k: k182940.
Additional Manufacturer Narrative
This report was previously submitted with the incorrect manufacturer registration number.
Event or Problem Description
During dialysis treatment, machine alarmed instantly for blood leak within the dialyzer, visible in the arterial coupler tubing.Patient was removed from the machine without returning the patient's blood (approximately 250ml of blood loss).Per charge nurse, patient required no follow up or transfusion post incident.Dialyzer used: f250 dialyzer machine: surdial dx hemodialysis system productg code: mc+sdx01 510k: k182940.

• 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: 18656043
• Report Number: 8041145-2024-00001
• Device Sequence Number: 7128486
• Product Code: FJK
• UDI-Device Identifier: 00383790008808
• UDI-Public: 00383790008808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Literature,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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: 22C18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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: Required Intervention
• Patient Sex: Unknown