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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-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.
 
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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 Key12287680
MDR Text Key265388676
Report Number3016250252-2021-00024
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K182940
Number of Events Reported1
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 Received08/06/2021
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
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
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