| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00125-1 |
| Product Name/Description |
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-AU031X
Multiple Lot Numbers affected (see attached)
ARTG Number: 138712 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Terumo are providing users additional instructions to check the cuvette is properly connected before use. |
| Contact Information |
02 8874 0302 - Terumo Australia |