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  Injury  

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,
• MDR Report Key: 18527881
• MDR Text Key: 333051301
• Report Number: 1056186-2024-00001
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00383790008808
• UDI-Public: 00383790008808
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

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
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2024
• Distributor Facility Aware Date: 12/21/2023
• Device Age: 21 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/17/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention