• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SHIBUYA (SBY) SURDIAL X HEMODIALYSIS MACHINE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURDIAL X
Type of DeviceHEMODIALYSIS 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 Key12278545
MDR Text Key265165433
Report Number3016250252-2021-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K182940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSURDIAL-X2-HDF-UJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
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 Treatment Data
Date Received: 08/04/2021 Patient Sequence Number: 1
-
-