MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO ELISIO-H DIALYZER

Model Number	DD+ELISIO-17H
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
Additional Manufacturer Narrative
Since the lot number was unknown, the investigation was performed on representative lot numbers.
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 blood tubing set w/tp, code: bl+a430/v912, lot 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 ELISIO-H DIALYZER
• Common Device Name: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• Manufacturer (Section G): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 19337295
• Report Number: 9610987-2024-00003
• Device Sequence Number: 11405289
• Product Code: KDI
• UDI-Device Identifier: 00383790007115
• UDI-Public: 00383790007115
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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: DD+ELISIO-17H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Male