| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00584-1 |
| Product Name/Description |
Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion Pumps
Product reference numbers: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G
Pumps manufactured between Dec 2009 and Jan 2012
ARTG number: 130389 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
Post market surveillance has identified an increased occurrence of stepper motor stalls due to the rear bearings not performing as designed.
A motor stall condition may occur during:
- Start up (immediately after the Start key is pressed) or;
- During an infusion which may result in the early termination of an infusion. Early termination of an infusion could require intervention especially if critical drugs are being administered.
In either case the pump is designed to fail safe giving an audible alarm, a visual alarm displayed on the infusion pump display - "DRV1" or "DRV2" and the red beacon light on the infusion pump will flash, prompting the infusion pump user to intervene. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are requested to identify all affected infusion pumps and report back to their Carefusion representative. On receipt of this information Carefusion will organise for the replacement of the motor.
The infusion pumps can be continued to be used in accordance with the instructions for use. In the unlikely event that end users experience a 'DRV1' or 'DRV2' error quarantine the pump and contact your Carefusion representative immediately. |
| Contact Information |
02 9624 9013 - Carefusion Regulatory Affairs |