| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00534-1 |
| Product Name/Description |
ARCTIC SUN 5000 Temperature Management System (220-240 V Australia)
Product Code: 5000-01-03
ARTG Number: 150422 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
An issue regarding the use of the ARCTIC SUN 5000 Temperature Management System, in excess of 2,000 system hours, without conducting preventative maintenance has been identified. This issue may result in failure of certain components, in particular, the mixing pump of the system. The mixing pump runs continuously during operation and its failure may cause the system to cease functioning as intended. Therefore, resulting in no availability of cooling or rewarming therapy for the patient.
To date, Bard Australia has not received adverse reports of injuries or diseases related to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard Australia is updating the Operators Manual and the Service Manual for the ARCTIC SUN 5000 Temperature Management System. Customers are advised to examine their inventory for affected devices to determine their total system hours of use by following the instructions detailed in the recall letter. Customers with devices approaching or exceeding 2,000 system hours are requested to contact their local Bard representative for further information. Customers with devices that have less than 2,000 hours are reminded to address potential issues before their occurrence in order to maintain device availability. In the event of a device failure, customers are advised to utilise alternative conventional methods for patient temperature control.
This action has been closed out on the 11/10/2018. |
| Contact Information |
02 8875 4070 - Bard Australia |