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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 04/30/2021
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
During the reinfusion, after dialysis treatment, the nurse witnessed air passing the clamp box, through the vnous line without the machine giving any alarm or operating the venous clamp. There were no injuries or consequences to the patient. Inspection was carried out by nipro service technician. The tech checked the clamp box for damage, then checked its calibration. No adjustment necessary. Ran machine through a simulated treatment and activated the air bubble alarm with actual air bubbles many times and saw that the clamp box was operating correctly. During reinfusion, the tech allowed the venous chamber run empty and the venous clamp again clamped the line and the air bubble alarm came up. 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 Key12287837
MDR Text Key265391971
Report Number3016250252-2021-00025
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 Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/05/2022
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
Date Manufacturer Received04/30/2021
Was Device Evaluated by Manufacturer? Yes
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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