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

Model Number SURDIAL-X2-HFDP-UJ

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 06/12/2020

Event Type  Death  

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 (b)(6) 2021.

Event Description

Customer stated that the patient was connected via central venous catheter to the dialysis machine.After approximately 10 minutes of dialysis treatment, the machine was alarming with low arterial pressure.Blood pump was stopped, and lines were reversed to improve arterial pressures and blood flow.Within 2 minutes the patient's condition deteriorated and, on examination, it became evident that a venous line disconnection had occurred.Fluid resuscitation was attempted but the patient passed away.No further information provided.

• 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: 12277856
• MDR Text Key: 265116988
• Report Number: 3016250252-2021-00002
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SURDIAL-X2-HFDP-UJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• 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): Death