| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01218-1 |
| Product Name/Description |
Gemstar Infusion System
Catalogue numbers: 611308801, 611308701
List number (number on the pump): 13000, 3087, 13088, 13150, 13100
ARTG number: 138109 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Through customer reports, Hospira has become aware that patients or unauthorised carers have been able to locate the default keypad lock code for Gemstar infusion pumps through internet searches in order to tamper with the programmed infusion parameters. Hospira have received no reports relating to this issue in Australia. One of the reports overseas resulted in a serious injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira is recommending users change the default keypad lock code upon receipt of the device and prior to delivery to patients, and remove the clinical instructions from the manual to prevent unauthorised access. Hospira will be providing users with an updated System Operating Manual to include the requirement to change the default keypad code. |
| Contact Information |
1300 046 774 (Option 1)- Hospira Australia |