| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01173-2 |
| Product Name/Description |
MetaVision ICU version 6.0x - 6.9x
ARTG Number: 165518 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
iMDsoft has received a complaint stating that there was a malfunction with the MetaVision ICU system that resulted in specific medication doses missing in multiple patient files. After an analysis of this complaint, iMDsoft determined that:
- one patient did not receive some specific planned doses that were prescribed. The problem in the software also identified to occur for few other patients, but in their case no actual doses were skipped. No grave patient outcomes have been reported.
- the cause was found to be a software malfunction in the MetaVision code which affected the behaviour of the Order Management Driver (OMD) - part of the MetaVision ICU Medication Management Module.
The software malfunction resulted in an unnoticed OMD failure which did not create specific medication doses of medication orders exceeded the horizon of 7 days per treatment plan. This led to the non-provision of specific medication doses to several patients. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Complete the supplied Customer Response and return it by email to FSN@imd-soft.com.
2. Contact iMDsoft Customer Support on 1800 240 919 to arrange a software upgrade to correct the problem.
This action has been closed out on 15/10/2018 |
| Contact Information |
1800 240 919 - iMDSoft Customer Support |