MAUDE Adverse Event Report: NIKKISO CO.,LTD DBB-05 HEMODIALYSIS DELIVERY SYSTEM; HIGH PERMEABILITY HEMODIALYZER

Model Number DBB-05

Device Problem False Alarm (1013)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2014

Event Type  Injury  

Manufacturer Narrative

From our local distributor we received the following information as to the reported event."second occurrence of this alarm where conductivity issues in this case acid canister empty may have caused the fault.From the alarm history the machine first had an issue due to the empty acid and then the treatment has been stopped and restarted 4 times in 5 minutes.Eventually being changed to hd mode and the patient being run back before the 141 alarm occurred.The air being drawn in from the empty cannister and from the hd change over are believed to have contributed to the 141 extra air removed alarm.Machine has been in use for two days since the alarm without fault and an additional test therapy has been run in the workshop without any problems and with the uf removal being found to be exact.Unit heat cleaned and returned to use." based on the above information, we evaluated that the reported event was not adverse event and there was no malfunction of the machine.

Event Description

Machine issued alarm tfd141 (suspected faulty float cell) which resulted in patient being disconnected from machine.This alarm is designed to pick up a failed float and alert the user to the issue.It can only do this by timing a release valve and if the valve is open for more than 60 seconds in a therapy or 5 seconds out of 10 it determines this to have been too long and flags the alarm.The valve opens to expel any air that has entered the system.This is not detrimental to the patient but can still trigger the tfd141 alarm if more than normal is observed.So what has happened is the alarm that would just have been reset in the past is now causing the machine to be pulled the float and adverse event report started as the customer is unsure if they have an actual failed float or just some extra air in the system.The failed floats were intermittent and were capable of functioning correctly for days before alarming again.

• Brand Name: DBB-05 HEMODIALYSIS DELIVERY SYSTEM
• Type of Device: HIGH 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 Key: 10982710
• MDR Text Key: 220638716
• Report Number: 8031561-2020-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBB-05
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 12/10/2020
• 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 Sequence Number: 1
• Treatment: BLOOD TUBING LINE : AV06JE-PDIALYZER
• Patient Outcome(s): Other