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U.S. Department of Health and Human Services

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

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SHIBUYA (SBY) SURDIAL X HEMODIALYSIS MACHINE Back to Search Results
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.
 
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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 Key12278030
MDR Text Key265151843
Report Number3016250252-2021-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeBE
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? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSURDIAL-X2-HFDP-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 Received12/04/2020
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
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