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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 Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2014
Event Type  Injury  
Event Description
Error code tfd141 issued by nikkiso dbb-06 dialysis machine (machine blood pump stopped). Blood pump restarted by attending nurse by pressing alarm reset. Patient blood returned through circuit back to patient. 300mls of saline administered to patient. Patient disconnected from machine. Patient did not display any adverse outcomes from the event. Nikkiso dialysis machine removed to workshop for evaluation and repair. Baxter technical service notified. Nikkiso dbb-06 dialysis machine tfd141 alarm. In this instance the patient was disconnected from the machine with no ill effect. The machine has removed from the treatment floor awaiting service from baxter technical service. (b)(4) will attend to the machine on monday on his return from leave. The dialysis unit (b)(6) has three spare machines she can use in the interim period if needed.
 
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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 Key10982697
MDR Text Key220640042
Report Number8031561-2020-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2014
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: 12/10/2020 Patient Sequence Number: 1
Treatment
BLOOD TUBING LINE : AV06JE-PDIALYZER
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