| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01222-1 |
| Product Name/Description |
DualHemo Mcable for use with the Infinity Acute Care System (IACS) (Patient monitoring system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
There have been reported cases in which the displayed value for the invasive blood pressure measurement of the IACS was lower than the actual patient
values were. Investigations have shown that liquid ingress in the cable connection of the DualHemo Mcable may cause inaccurate measurements.
Further investigation revealed that this can happen if the DualHemo Mcable is used in a non-vertical position or vertically but top down instead of top up, or if it
is simply laid down on the floor or on the patient bed and is not adequately positioned. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Drager Medical GmbH is providing an amendment to the instructions for use describing the correct orientation of the DualHemo Mcable when in use. |
| Contact Information |
03 9244 7248 - Sue Connolly |