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

Model Number DBB-06

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2014

Event Type  Injury  

Manufacturer Narrative

From our local distributor we received the following information as to the reported event.Unit completed two test therapies with accurate uf and no alarms.History review showed multiple patient pressure alarms from the beginning of the failed therapy indicating access problems.Set eventually clotted and was removed, alarm happened immediately after priming of new set and so is believed to have been caused by the additional air removal in priming which means the machine was functioning correctly.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 alarmed tfd141, float switch abnormal during treatment x 2, bloodlines clotted on both occasions, patient lost 2 circuits of blood.This alarm is designed to pick up 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 and 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 off the floor and an 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-06 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: 10982737
• MDR Text Key: 220638813
• Report Number: 8031561-2020-00005
• 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

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBB-06
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• 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