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 Code	Loss of consciousness (2418)
Date of Event	04/23/2024
Type of Reportable Event	Death
Event or Problem Description
Patient coded at the end of 3.5hour treatment.Patient became unresponsive while returning blood, no pulse, chest compressions were started along with high flow oxygen until paramedics arrived.Cpr was started and stopped after 25 minutes.Dialysis treatment: 3.5hours 3 times a week, 1.0k, 2.5 ca, 37 bicarb, 140 na.

• 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: 19525369
• Report Number: 1056186-2024-00008
• Device Sequence Number: 15345917
• 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): 06/12/2024
• Report Date (Section F): 06/12/2024

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
• Device Model Number: BL+A209Y/V803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 06/12/2024