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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 Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)
Patient Problems Cramp(s) (2193); Weight Changes (2607)
Event Date 08/01/2017
Event Type  Injury  
Manufacturer Narrative
Based on the reported information of tfd141 lvs(level switch) alarm, we presume the following scenario as a probable cause of this event. When certain amounts of deaerated air comes into the gs (gas separator) 2 chamber, the lvs is activated and the valve is opened to drain the deaerated air. If the valve is open for more than 60 seconds in a therapy or 5 seconds out of 10, the tfd141 lvs alarm is triggered to alert the operator. If the lvs is activated by some other reason, some dialysis fluid may be lost to drain, and it might cause unexpected fluid loss. However, under tfd141 alarm, the machine stops to supply /suction dialysis fluid to/from dialyzer, and it is confirmed that there is no additional fluid loss while the alarm is activated. In the operator's manual of the dbb-06, the operator's intervention for this alarm is described: ". To not repeat to "reset" the alarm if it was triggered again, and to contact a trained technical staff. " in the reported event, the tfd141 lvs alarm was triggered several times during the treatment, but each tfd141 alarm was reset by the nurse.
 
Event Description
Patient (b)(6) was set for (b)(6) kg goal; (3. 5 hours). On (b)(6) 2017 during dialysis treatment, the patient became symptomatic about one hour and a half into the treatment. The patient started to complain about left leg cramping, then arm, ribs and then abdomen. It was at that point that the patient's blood was returned and treatment was terminated. The machine displayed tfd141 lvs alarm several times during the treatment, but it was reset by the nurse. The nurse discovered the discrepancy between the uf on the screen and uf entered so he weighed the patient and discovered that the patient lost (b)(6) kg, (not (b)(6) kg as stated on the screen). The patient was treated at the dialysis clinic with 500-700 ml of normal saline. Symptoms were relieved and patient was discharged home in stable condition. The patient returned for his next dialysis treatment on (b)(6) 2017. The treatment was tolerated well with the exception of some mild cramping at the end of the treatment. The patient is a latino construction worker and is not consistent with scheduled treatment for the week (patient missed (b)(6)) then dialyzed again on (b)(6) 2017 without any issues.
 
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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 Key10982893
MDR Text Key220650602
Report Number8031561-2020-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2017
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,DIALYZER
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