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

Model Number SURDIAL-X2-HDF-UJ

Device Problems Pumping Stopped (1503); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2021

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 detemined on july 8, 2021.

Event Description

On february 22nd, 2021 was reported that 40 minutes before the end of a dialysis session, the blood pump of the dialysis machine surdial-x2-hdf-uj bearing serial number (b)(4) stopped without any alarm.According to the nurse, the machine stayed without blood pump functioning for 30 minutes.Therefore, the blood in the extra corporeal circuit coagulated both in the arterial and the venous side.As consequence, since the blood could not be re-infused, the patient lost around 300ml of blood and the treatment was completed on another machine.Furthermore, the main control board of the machine was replaced, but a noise from the speaker was heard and a damaged wire in the articulation of the screen was found.

• 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: 12278545
• MDR Text Key: 265165433
• Report Number: 3016250252-2021-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SURDIAL-X2-HDF-UJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• 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): Other