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

Model Number MC+SDX01

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Confusion/ Disorientation (2553)

Event Date 10/22/2022

Event Type  malfunction  

Event Description

Approximately 2 hours into dialysis treatment a patient had significant blood loss from venous needle connection.Facility administrator stated the connection was loose.They placed towels on the floor surrounding the blood and estimated 2-24 inches of blood.Vitals taken at 11:30am were stable and access was visualized.At about 11:45am, patient seemed confused and blood pressure was 70/38.The team was able to secure the line and return the patient's blood.Patient was then sent to the hospital for blood transfusion and observation, subsequently requiring 2nd blood transfusion.Patient returned to regular dialysis treatment on (b)(6) 2022 without complications.Other devices used: nipro blood tubing set w/tp.Product code: (b)(4).Lot#: 21a11.

• Brand Name: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
• Type of Device: 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: 15811610
• MDR Text Key: 307110410
• Report Number: 3016250252-2022-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790008815
• UDI-Public: 00383790008815
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC+SDX01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization