| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00493-1 |
| Product Name/Description |
Injectomat Agilia Range (Std, MC & TIVA), Volumat Agilia Range (Std & MC) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Frensenius Kabi initiated a software upgrade due to three incident reports concerning three different issues:
Injectomat and Volumat pumps:
1. The PDMS from Picis implemented an unexpected high number of connection/disconection requests resulting in a "Watchdog" error message.
2. If the user configured the Vigilant Drug Lib software with a drug with fixed dilutions, the selection on the pump of this drug as a first step then followed by the selection of 'Drug X in mL/hr' as a second step could result in the display of a technical error.
Concerning Injectomat pumps:
3. In a high vibration environment, for example close to the warming device, the syringe installation check sensor signal can be unstablepotentially triggering a technical error (n-deg 23).
This action was undertaken prior to notifying the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Fresenius Kabi has updated the software of all affected Injectomat and Volumat devices. |
| Contact Information |
02 9391 5590 - Fresenius Kabi Australia |