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

Model Number	DD+ELISIO-15H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Convulsion/Seizure (4406)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
58 minutes into a two-hour dialysis treatment the affected patient started vomiting and subsequently had a witnessed grand-mal seizure.This lasted 1-2 minutes and then subsided.The treatment was ended with a total of 489 ml uf(ultrafiltration).Ems was dispatched and by the time they arrived in the facility the patient was fully conscious and recovered from the event.The nurse noted that there was no change in vital signs before the event, and no indication to her that there was an impending event.This patient is an established dialysis patient with no history of seizures.Per the nurse, after the event the patients blood pressure was slightly elevated, but within normal range.The patient was taken to the hospital and cleared to return back to the nursing home that same day.The patient received dialysis treatments wednesday(b)(6) 2022, thursday (b)(6) 2022 and friday (b)(6) 2022 with no adverse events.(b)(6) 2022: rn said patient dialyzed with no issues.Patient had history of stroke but no history of seizures.Per nurse, no medications were given during the treatment when the event happened, and no new medication was started.Patient has cvc but had avf surgery (b)(6) 2022.Vital signs: pre tx: bp = 103/48, pulse = 90, temp = 97.5, rr = 20 start of tx: bp = 137/67, p = 81 during the event: bp = 142/119, p = 81 post tx: 175/76, p = 95, temp = 96.2, rr = 22 edw: 100.5 kg.Pt came with 100.8 kg but has been losing weight and they have had to change edw for several times for over a month.Nurse informed the team that patient had been losing weight and is on dietary evaluation.Other devices used during event:: nipro elisio 15h: dd+elisio-15h - lot # 21j14f nipro blood tubing set: product code- bl+a430/v912 - lot # 20f15 citric acid: ac -200 - nurse was not sure what was the lot # used during the treatment.Following lot #s in the unit: n2b009, n2b007 and n1h007.

• 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
• MDR Report Key: 14469500
• Report Number: 1056186-2022-00002
• Device Sequence Number: 4570195
• Product Code: KDI
• UDI-Device Identifier: 00383790007108
• UDI-Public: 00383790007108
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/23/2022
• Report Date (Section F): 05/23/2022

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 Expiration Date: 09/30/2024
• Device Model Number: DD+ELISIO-15H
• Device Catalogue Number: DD+ELISIO-17H
• Device Lot Number: 21J14F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/22/2022
• Device Age: 6 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2022
• 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: Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/23/2022