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

Model Number BL+A430/V912

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

This report was previously submitted with the incorrect manufacturer registration number.

Event 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.

Manufacturer Narrative

This report was previously submitted with the incorrect manufacturer registration number.

Event 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
• Type of Device: 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
• MDR Text Key: 335316217
• Report Number: 8041145-2024-00001
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention