Events

Recall of DBB-06, DBB-07 Haemodialysis Device (haemofiltration dialysis unit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare 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-2012-RN-01202-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01202-1
  • 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
    Nikkiso has received complaints regarding too high a patient leakage current with the dbb-06 devices, used in combination with a central venous catheter (cvc). these complaints were related to technical measurement without any patient involvement.
  • Action
    Baxter Healthcare is recommending work around instructions to mitigate the risk. A modification to the hardware is planned to correct the issue.

Device

DBB-06, DBB-07 Haemodialysis Device (haemofiltration dialysis unit)
  • Model / Serial
    DBB-06, DBB-07 Haemodialysis Device (haemofiltration dialysis unit)Reference Numbers: GE-F110-00, GE-F111-00, GE-F112-00, GE-F114-00 & GE-F115-00All devices with serial numbers manufactured prior to 1 October 2012ARTG Number: 189947
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd