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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIBUYA (SBY) NIPRO SURDIAL DX HEMODIALYSIS SYSTEM HEMODIALYSIS MACHINE

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SHIBUYA (SBY) NIPRO SURDIAL DX HEMODIALYSIS SYSTEM HEMODIALYSIS MACHINE Back to Search Results
Catalog Number SURDIAL X
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Detachment of Device or Device Component (2907)
Patient Problem Burn(s) (1757)
Event Date 06/24/2021
Event Type  Injury  
Event Description
We have been informed about an incident where a nurse had contact with hot water while cleaning the hemodialysis machine. The machine was put into hot disinfection and the nurse continued cleaning / disinfecting the surface of the machine. While she was doing this, suddenly the silicone tube from the b-nozzle (bicarb nozzle) on the bsp panel (blood pump / syringe pump panel) side "popped-off" and hot water was spilled over her leg. She was suffering and showing signs of scalding. No additional information has been received at this time.
 
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Brand NameNIPRO SURDIAL DX HEMODIALYSIS SYSTEM
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 Key12609373
MDR Text Key275895858
Report Number3016250252-2021-00027
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeGM
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 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSURDIAL X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No
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: 10/11/2021 Patient Sequence Number: 1
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