Events

Recall of 4008 HD BloodlinesAV/FRES 2008-4008 (F00007119)AV/FRES 4008 (F00007120)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Medical Care Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00285-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00285-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Fresenius medical care has been made aware of incidents regarding quality, safety and performance of the 4008 hd bloodlines tubing. the currently supplied roller clamp may cause customers to experience difficulties in handling that might result in excessive force being used to close the clamp causing the roller part to detach. this may cause infusion of saline solution in the event of incorrect use of the roller clamp, if the second clamp present on the arterial line is also damaged or not closed. a number of leakages were reported at several locations on the 4008 bloodline tubing systems. leakages on the bloodlines may cause blood loss into the environment and may lead to air intake into the system. while the air intake is normally detected by the dialysis machine’s air detector, a leakage of blood may not be detected.
  • Action
    Until further investigations are complete, Fresenius recommend that the Instructions for Use in each carton box of the HD bloodlines be followed, namely: 1. Ensure that all caps and connections are secure; and 2. Inspect the extracorporeal circuit for leaks during priming phase and treatment, taking corrective measures (e.g. tightening Luer-Lock connection) or exchanging the bloodline as necessary. Ensure that no excessive force is applied on the roller clamp on the reinfusion set in order to regulate the flow of fluid through the infusion pathway. Fresenius are currently investigating and working to address the issues with the tubing.

Device

4008 HD BloodlinesAV/FRES 2008-4008 (F00007119)AV/FRES 4008 (F00007120)
  • Model / Serial
    4008 HD BloodlinesAV/FRES 2008-4008 (F00007119)AV/FRES 4008 (F00007120)ARTG Number: 117268Fresenius Medical Care Australia - Tubing set, dialysis/haemodialysis
  • Manufacturer
    Fresenius Medical Care Australia Pty Ltd

Manufacturer

Fresenius Medical Care Australia Pty Ltd