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

Model Number	BL+A209Y/V803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Low Oxygen Saturation (2477)
Date of Event	01/06/2024
Type of Reportable Event	Death
Event or Problem Description
Patient's bp dropped to 93/49 about 15 mins before end of treatment.O2 saturation dropped to 80% and medical emergency activated, 911 called.Patient became unconscious with no pulse.Investigation on dialysis products involved when patient expired during treatment per facility policy.Used blood line saved by facility for investigation.Other devices used: nipro safe touch tulip, code and lot unknown.Dialysis settings: 3 hrs, 2k2.5ca, bfr 350, dfr 700, 3x/ week treatment.

• 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,
• MDR Report Key: 18794478
• Report Number: 1056186-2024-00003
• Device Sequence Number: 20656821
• Product Code: FJK
• UDI-Device Identifier: 00383790004053
• UDI-Public: 00383790004053
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2024
• Report Date (Section F): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BL+A209Y/V803
• Device Lot Number: 22F22
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/13/2024
• Device Age: 19 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 02/27/2024