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

Model Number MC+SDX01

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

Patient Problems Loss of consciousness (2418); Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)

Event Date 04/29/2022

Event Type  Death  

Event Description

At 10: 54 am, with 34 minutes into a 2.5 hrs treatment, patient said he needs to use the restroom due to bowel movement and was restless, bp was 84/42 mmhg, p=67.Staff put patient on t position and staff noticed after that patient had a blank stare and was unresponsive.Nurse was called, blood was returned, and treatment was ended.Nurse did a chest rub, gave oxygen and 911 was called.At 11:03 am blood sugar was 113mg/dl.11:06 am - bp was 127/66, p 119, but respiratory rate was only 2 and nurse was giving oxygen through ambu bag.Paramedics came and pronounced the patient deceased at 11:17 am.Family was contacted and decided not to send patient to the hospital.Patient had previously signed a dnr on (b)(6) 2022.Patient has a history of non-compliance, missing and not completing treatments.Patient treatment orders/information: tx time - 2.5 hrs; bfr - 300; dfr - 500; edw - (b)(6).Patient came in @ (b)(6), goal set at 600 ml.Bp at start of treatment - 90/51 mmhg, p= 66.Only heparin 2000 units was given.No new medications started.Other products used during the event: nipro elisio-15h dialyzer - 21j14f; nipro blood tubgin set - 20f15; nipro avf tulip needle - 21j06b; citric acid - ac-200 - n1h007.

• Brand Name: SURDIAL DX HEMODIALYSIS SYSTEM AND ACCESSORIES
• Type of Device: HEMODIALYSIS MACHINE
• Manufacturer (Section D): SHIBUYA (SBY); 2-72, wakamiya; kanazawa, isikawa 920-0 054; JA 920-0054
• MDR Report Key: 14478197
• MDR Text Key: 292469267
• Report Number: 1056186-2022-00008
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790008815
• UDI-Public: 00383790008815
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• 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: MC+SDX01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2022
• Distributor Facility Aware Date: 04/29/2022
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR