| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00248-1 |
| Product Name/Description |
All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy Infusion System
GemStar Infusion System - Single Therapy
Catalogue Number: 611308801
Number on Pump: 13088 / 13150
GemStar 7 Therapy Infusion System
Catalogue Number: 611308701
Number on Pump: 13087 / 13000 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
A lithium battery, that is not user accessible, is used to power the memory that stores the current infusion settings and the event history logs when the pump is turned off. If the battery’s voltage level drops below 2.4 volts, an 11/004 error will be displayed and the device will not be able to be used, resulting in a possible delay/interruption in therapy. Additionally, the infusion settings and event history logs will be erased. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If the GemStar device displays an 11/004 error, users are advised to immediately remove it from clinical service and return it to Hospira for battery replacement. Lithium batteries that are older than five (5) years should be replaced. A preventative maintenance program is being developed to ensure the lithium batteries are changed out prior to the end of life.
Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which delay/interruption in therapy or under/over infusion could result in significant injury or death. |
| Contact Information |
1300 046 774 (OPTION 1) - Hospira Customer Service |