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

Model Number SURDIAL-X2-HDF-UJ

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

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 a dialysis treatment, air passed through the bubble detector but the machine did not alarm and the venous clamp did not activate. A nurse witnessed the event and stopped the blood pump, preventing air from entering the patient. There was no injury or influence to the patient. Inspection was carried out by nipro service technician. The tech checked the physical condition of the clamp box (all ok) and then checked the calibration. The tech re-calibrated the machine, then tested its function many times during simulated treatment and the machine worked as intended. The machine is currently being used at the facility.

• 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: 12287680
• MDR Text Key: 265388676
• Report Number: 3016250252-2021-00024
• 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: 08/05/2021

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?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SURDIAL-X2-HDF-UJ
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/06/2021 Patient Sequence Number: 1