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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 Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 02/11/2019
Event Type  Injury  
Event Description
During dialysis, tfd 141 float switch abnormal alarm occured only one time. Uf removal of the patient was 800ml excess. Patient condition was normal. Gas separator 2 chamber assy x06-064w02 was replaced. After the replacement, pressure calibration, uf accuracy testing, self-test & simulation of the dialysis treatment four times. No problem observed. Machine serial no. (b)(4) is working without problem.
 
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Brand NameDBB-06 HEMODIALYSIS DELIVERY SYSTEM
Type of DeviceHIGH PERMEABILITY HEMODIALYZER,
Manufacturer (Section D)
NIKKISO CO.,LTD
nikkiso.pms@nikkiso.co.jp
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 Key11073620
MDR Text Key224033428
Report Number8031561-2020-00009
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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