MAUDE Adverse Event Report: SHIBUYA (SBY) SURDIAL DX HEMODIALYSIS SYSTEM AND ACCESSORIES; HEMODIALYSIS MACHINE

Model Number	MC+SDX01
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: 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.
Additional Manufacturer Narrative
Serial number reported in initial submission was incorrect.Revised section d4 to reflect the correct machine serial number.
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 (b)(6) 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: 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: SURDIAL DX HEMODIALYSIS SYSTEM AND ACCESSORIES
• Common Device Name: HEMODIALYSIS MACHINE
• Manufacturer (Section D): SHIBUYA (SBY); 2-72, wakamiya; kanazawa, isikawa 920-0 054; JA 920-0054
• Manufacturer (Section G): SHIBUYA (SBY); 2-72, wakamiya; kanazawa, isikawa 920-0 054; JA 920-0054
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 14470001
• Report Number: 3016250252-2022-00003
• Device Sequence Number: 4570760
• Product Code: KDI
• UDI-Device Identifier: 00383790008815
• UDI-Public: 00383790008815
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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 Model Number: MC+SDX01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown