MAUDE Adverse Event Report: SHIBUYA (SBY) NIPRO SURDIAL DX HEMODIALYSIS SYSTEM; DIALYSIS MACHINE

Model Number	MC+SDX01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/03/2024
Type of Reportable Event	Death
Event or Problem Description
Patient was admitted to the hospital on (b)(6) 2024 due to low oxygen saturation and gi issues, discharged from the hospital on (b)(6) "2024." it was her first treatment in the clinic post hospitalization.Treatment started 7:07am with a blood pressure (bp) of 110/49 and it started dropping.7:30 - bp 93/43 mm/hg: 8:00 - bp 95/52 mm/hg and 9 am - bp was 99/38 mm/hg and they stopped the ultrafiltration (uf).Patient started vomiting and passed out, cpr was performed, fluids were given and paramedics were called.They tried ending the treatment but were unable to until after patient was pronounced dead @ 10:24 am.Dialyzer/bloodlines were saved.Staff stated that there were no alarms triggered before or during the event, except for treatment related alarms prior to event.Cause of death is still unknown.There were no issues reported with any of the nipro devices used.Treatment time - 3.5 hrs; blood flow rate (bfr) - 250; dialysate flow rate (dfr) - 600; a/b - 3k, 2.5; bicarb - 35, temp - 35.5; na - 138; access: cvc; uf goal - 4l; uf removed - 1.5 l; estimated dry weight (edw) - 74 kg; pre weight - 77.5 kg medications given; mircera - 60 mcg; venofer - 50 mg comorbids: cancer, chronic obstruction pulmonary disease (copd) machine s/n: (b)(6).Machine pulled out of service; dialysate samples were drawn.Other devices use: nipro blood tubing set, code: bl+a430/v912, lot# 23k29.Nipro elisio-h dialyzer, code: dd+elisio-17h, lot# 24c28h.
Event or Problem Description
Patient was admitted to the hospital on 06/21/2024 due to low oxygen saturation and gi issues, discharged from the hospital 07/02/202024.It was her first treatment in the clinic post hospitalization.Treatment started 7:07am with a blood pressure (bp) of 110/49 and it started dropping.7:30 - bp 93/43 mm/hg: 8:00 - bp 95/52 mm/hg and 9 am - bp was 99/38 mm/hg and they stopped the ultrafiltration (uf).Patient started vomiting and passed out, cpr was performed, fluids were given and paramedics were called.They tried ending the treatment but were unable to until after patient was pronounced dead @ 10:24 am.Dialyzer/bloodlines were saved.Staff stated that there were no alarms triggered before or during the event, except for treatment related alarms prior to event.Cause of death is still unknown.There were no issues reported with any of the nipro devices used.Treatment time - 3.5 hrs; blood flow rate (bfr) - 250; dialysate flow rate (dfr) - 600; a/b - 3k, 2.5; bicarb - 35, temp - 35.5; na - 138; access: cvc; uf goal - 4l; uf removed - 1.5 l; estimated dry weight (edw) - 74 kg; pre weight - 77.5 kg medications given; mircera - 60 mcg; venofer - 50 mg comorbids: cancer, chronic obstruction pulmonary disease (copd) machine s/n: 22ew0301.Machine pulled out of service, dialysate samples were drawn.Other devices use: nipro blood tubing set, code: bl+a430/v912, lot# 23k29 nipro elisio-h dialyzer, code: dd+elisio-17h, lot# 24c28h.

• Brand Name: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
• Common Device Name: DIALYSIS 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: 19889324
• Report Number: 3016250252-2024-00003
• Device Sequence Number: 18049451
• Product Code: KDI
• UDI-Device Identifier: 00383790008815
• UDI-Public: 00383790008815
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: MC+SDX01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Sex: Female