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

Model Number SURDIAL-X2-HFDP-UJ

Device Problem Insufficient Information (3190)

Patient Problem Dizziness (2194)

Event Date 03/12/2021

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

The dialysis machine was giving an arterial pressure alarm.This alarm had been reset and after this, an air bubble detection alarm occurred.The clamps of the device and the catheter had been closed to ensure the patient's safety.The catheter had been flushed once and reconnected to continue treatment, then it was noticed that arterial air had entered the circuit.Patient became dizzy and unwell.As a first intervention the patient was placed in trendelenburg position and on the left side.Oxygen was provided via an oxygen mask.Patient was disconnected and had a good recovery.Ekg (electrocardiograph), tte (transthoracic echocardiogram) and ct angiography were ordered by the physician.No further information has been provided.

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

The dialysis machine was giving an arterial pressure alarm.This alarm had been reset and after this, an air bubble detection alarm occurred.The clamps of the device and the catheter had been closed to ensure the patient's safety.The catheter had been flushed once and reconnected to continue treatment, then it was noticed that arterial air had entered the circuit.Patient became dizzy and unwell.As a first intervention the patient was placed in trendlenburg position and on the left side.Oxygen was provided via an oxygen mask.Patient was disconnected and had a good recovery.Ekg (electrocardiograph), tte (transthoracic echocardiogram) and ct angiography were ordered by the physician.No further information has been 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: 12287471
• MDR Text Key: 265379614
• Report Number: 3016250252-2021-00023
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2021
• 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