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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00187-1
Product Name/Description Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter Monitoring System 500

Multiple Product Codes affected
Multiple Batch Numbers affected

ARTG Number: 158341
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/02/2016
Responsible Entity Lovell Surgical Supplies International Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 03 9775 1855 - Lovell Surgical Supplies