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

Model Number SURDIAL-X2-HFDP-UJ

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 10/10/2020

Event Type  Injury  

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

An episode of air embolism occurred while using the nipro dialysis machine surdial¿ x bearing the serial number (b)(4).It was confirmed that the arterial pressure was strongly negative since the beginning of the treatment, but the alarm (e024) was reset several times during the dialysis process by the nurse who tried to solve the issue of the negative pressure by disconnecting the arterial bloodline and connecting a syringe to flush the catheter.Following that operation, the patient showed signs of air embolism feeling unwell for about 1 minute.As a consequence, the doctor acted fast by placing the patient in a flat position and the conditions stabilized.The patient had no lasting symptoms.

• 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: 12278030
• MDR Text Key: 265151843
• Report Number: 3016250252-2021-00003
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K182940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/04/2021

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
• Device Operator: Health Professional
• Device Model Number: SURDIAL-X2-HFDP-UJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 08/04/2021
• 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): Required Intervention