| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00547-1 |
| Product Name/Description |
Arctic Sun 5000 Australia
Catalog Number: 5000-01-03
Serial Numbers: All serials software versions v3.0.2 and prior
ARTG 150422
(Bard Australia Pty Ltd - Heating unit, pad, water, control unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Alarm 113 may not alert as expected when the device fails to reach the correct target water temperature while the device is operating in patient control mode. Alarm 113 is for “Reduced Water Temperature Control”; The system has detected that the water temperature has not been controlled as accurately as expected in the last 30 minutes. This situation may be temporary due to sudden patient temperature changes, interruption in water flow, or blockage of air flow by an obstruction or dirty filter. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
BD will contact customers to arrange a software upgrade to correct the problem upon receipt of the acknowledgement form.
In the interim, customers can continue to utilise the device with the following guidance:
1. The Arctic Sun Temperature Management System contains two fixed alarms when the device is operating in patient control mode. Alarm 10 if patient's temperature and water temperature is below 31 degrees Celcius. Alarm 08 will alert if the patient's temperature and water temperature is above 39.5 degrees Celcius. These alarms are already configured on the device.
2. BD recommends that customers continue to use the customisable Patient Temperature Low (Alarm 11) and Patient Temeprature High (Alarm 09) on their devices.
3. As per the operating manual, always empty the Artic Gel Pads when therapy is ended, even if the stop in therapy is temporary. |
| Contact Information |
1800 656 100 - BD Customer Service |