MAUDE Adverse Event Report: SHIBUYA (SBY) SURDIAL X; HEMODIALYSIS MACHINE

Model Number SURDIAL-X2-HD-UJ

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Low Blood Pressure/ Hypotension (1914); Weight Changes (2607)

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer evaluated the device in question and determined that the device is similar to 510k# k182940, therefore mdr reportability was determined on july 8, 2021.

Event Description

During dialysis treatment, the machine's ultrafiltration was programmed to take 2.1l off, but instead removed 3.3l.Patient's treatment was terminated 7 minutes earlier.Patient's lowest blood pressure was 120/46.No further information was provided.

Event Description

During dialysis treatment, the machine's ultrafiltration was programmed to take 2.1l off, but instead removed 3.3l.Patient's treatment was terminated 7 minutes earlier.Patient's lowest blood pressure was 120/46.No further information was provided.

Manufacturer Narrative

The manufacturer evaluated the device in question and determined that the device is similar to 510k# k182940, therefore mdr reportability was detemined on july 8, 2021.

• Brand Name: SURDIAL X
• Type of Device: 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: 12285227
• MDR Text Key: 265365910
• Report Number: 3016250252-2021-00018
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K182940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SURDIAL-X2-HD-UJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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