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

Model Number	BL+A430/V912
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908)
Date of Event	04/11/2024
Type of Reportable Event	Death
Event or Problem Description
3 hours and 46 minutes into dialysis treatment patient had a cardiac episode.Facility stated that they noted the patient to have arrived with hypertension prior to treatment.Blood pressure (bp) at 05:18am 211/100 heart rate (hr) 82, bp at 05:40am 220/86 hr 78.Treatment initiated at 05:50am (bp) at 196/110 (hr) 80.Ultrafiltration (ufr) reduced to 0.1 at 9:34am with bp 178/97 6 minutes prior and bp 183/89 8 minutes post.Machine alarmed with all blood pressure readings out of parameters.Treatment interrupted at 9:43am, reinfusion started with a total reinfusion volume of 300ml.At 9:57am bp 155/147 hr 168, 9:59am bp 203/167 hr 60, 10:00am bp 126/82 hr 77, 10:02am bp 126/28 hr 96.Dialysate flow rate (dfr): 700 blood flow rate (bfr): 400, then lowered to 375, then again to 350 during treatment uf goal 3.5.Other devices used nipro surdial dx hemodialysis system, 510k: k182940, serial# (b)(6) nipro elisio-h dialyzer, code dd+elisio-17h, lot number unknown.Facility did not retain the lot numbers used for the dialyzer or bloodline.Actual samples were discarded by the facility.Per facility patient did not have any recent hospitalization and no cause of death was provided.Multiple attempts made to obtain additional information, with no success.

• 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: 19337528
• Report Number: 1056186-2024-00007
• Device Sequence Number: 16789789
• Product Code: FJK
• UDI-Device Identifier: 00383790008808
• UDI-Public: 00383790008808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/16/2024
• Report Date (Section F): 05/16/2024

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+A430/V912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• 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: Other; Death
• Patient Sex: Male
• Date Report Sent to FDA: 05/16/2024