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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIKKISO CO.,LTD DBB-06 HEMODIALYSIS DELIVERY SYSTEM HIGH PERMEABILITY HEMODIALYZER

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NIKKISO CO.,LTD DBB-06 HEMODIALYSIS DELIVERY SYSTEM HIGH PERMEABILITY HEMODIALYZER Back to Search Results
Model Number DBB-06
Device Problem Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 02/11/2019
Event Type  Injury  
Event Description
Dialysis treatment 4:00 hrs start at 09:20. Dialysis treatment was stopped at 10:06. Dialysis stopped within 40 minutes after starting due to tfd141 float switch abnormal. Earlier experiences of uf excess removed technician stopped dialysis for safety from his experience of uf removal excess. Uf goal set 2800ml for 4 hrs. Uf removed display400 ml during 0:40 minutes of dialysis, but actual removal of the patient was 800ml. Patient condition was normal. We changed gas separator 2. To new one and the machine went back to original condition. Back pressure valve h1 was calibrated. Back pressure valve h2 was calibrated. Valve l was calibrated (balance check with 20ml done). Self-test passed. Simulation of the dialysis treatment with saline to conform 100% accuracy on uf removal.
 
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Brand NameDBB-06 HEMODIALYSIS DELIVERY SYSTEM
Type of DeviceHIGH PERMEABILITY HEMODIALYZER
Manufacturer (Section D)
NIKKISO CO.,LTD
20-3, ebisu 4-chome
shibuya-ku
tokyo, 150-6 022
JA 150-6022
Manufacturer (Section G)
NIKKISO CO.,LTD
498-1
shizutani
makinohara-shi, shizuoka 421-0 496
JA 421-0496
Manufacturer Contact
toshio ohmori
20-3,ebisu 4-chome
shibuya-ku
tokyo, 150-6-022
JA   150-6022
MDR Report Key11073619
MDR Text Key224034352
Report Number8031561-2020-00008
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 12/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDBB-06
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2019
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: 12/25/2020 Patient Sequence Number: 1
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