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

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.

• 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: 10982697
• MDR Text Key: 220640042
• Report Number: 8031561-2020-00003
• 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-06
• 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: 09/02/2014
• 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