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

Model Number BL+A430/V912

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Convulsion/Seizure (4406)

Event Date 04/19/2022

Event Type  Injury  

Event 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 surdial dx hemodialysis machine: mc+sdx01, serial# (b)(4).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 BLOOD TUBING SET W/TP
• Type of Device: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 14469711
• MDR Text Key: 294776345
• Report Number: 8041145-2022-00003
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00383790007108
• UDI-Public: 00383790007108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL+A430/V912
• Device Catalogue Number: DD+ELISIO-17H
• Device Lot Number: 20F15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization