Events

Recall of Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulmonary bypass)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Terumo 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-2016-RN-00125-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00125-1
  • 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
    Terumo cardiovascular systems (terumo cvs) has received complaints of the cdi system 500 monitor displaying the “h/s disconnect at cuvette” error message when the cdi h/s cuvette does not make a proper connection to the cdi h/s probe. in this situation, blood parameter values for hct, hgb, and so2 do not display. if failure of the cdi h/s cuvette connection is recognized after initiation of cardiopulmonary bypass (cpb), the clinician will have to choose between changing out the cuvette (which requires the interruption of cpb for an indeterminate amount of time) or relying on intermittent discreet blood gas analysis values to trend hematocrit/saturation (h/sat) values.
  • Action
    Terumo are providing users additional instructions to check the cuvette is properly connected before use.

Device

Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulm...
  • Model / Serial
    Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulmonary bypass)Catalogue Numbers: 6912, 6913, 6914, 6922, 6923, 6924, CX-AU031XMultiple Lot Numbers affected (see attached)ARTG Number: 138712
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd