Events

Recall of Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter Monitoring System 500

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Lovell Surgical Supplies International 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-00187-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00187-1
  • 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
    The terumo cdi h/s cuvette is included in some cardiopulmonary bypass packs supplied by lovell surgical supplies international.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 recognised 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 haematocrit/saturation (h/sat) values.
  • Action
    Lovell Surgical Supplies is providing users additional instructions to check the cuvette is properly connected before use. Thia action has been closed-out on 19/01/2016.

Device

Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter...
  • Model / Serial
    Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter Monitoring System 500Multiple Product Codes affectedMultiple Batch Numbers affectedARTG Number: 158341
  • Manufacturer
    Lovell Surgical Supplies International Pty Ltd

Manufacturer

Lovell Surgical Supplies International Pty Ltd