| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01620-1 |
| Product Name/Description |
Artiset HD SN HC Bloodlines (blood tubing system used for haemodialysis with Artis system)
Product Code: 114533
Lot Numbers: 1634 and onwards
ARTG Number: 141589 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare has identified, during post-market surveillance activities, the potential for disconnection of the Artiset bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. The post-market surveillance reports of disconnection of the Artiset bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices.
Inadvertant disconnection of the bloodline from the patient access site due to an improper connection of the access line could result in serious adverse health consequences such as an air embolism and/or blood loss. Baxter has received sporadic events reporting of inappropriate connections between the bloodline and the patient access site, resulting in external blood loss for the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Baxter is providing users with additional instructions on how to properly connect and to avoid a disconnection, as follows:
1. Insert the male luer cone in the female connector. Stop upon perception of complete adherence between the two components.
2. Screw the male luer coupling nut on the female component until perception of the end stop.
3. After the connection is completed, check that the male luer coupling nut is firmly screwed.
During the whole connection procedure for both arterial and venous patient lines (red and blue coupling nuts), hold and screw the male luer coupling nut only. Do not apply the screwing torque to the male luer body.
This action has been closed out on the 09/10/2018. |
| Contact Information |
03 9389 3058 - Baxter |