| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00246-1 |
| 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 I |
| Recall Action Commencement Date |
12/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
During infusions at flow rates of less than 2.0mL/hr , the motor assembly may rotate backwards (roll back), capturing additional medication that will be delivered resulting in over-infusion. Additionally, users may receive X09/001 backward motor movement alarms during the device’s Power On Self Test (POST) or during an infusion. This alarm will invoke visual and audible warnings to the user and the infusion will not begin or an active therapy will stop, resulting in a delay or interruption in therapy. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira is advising customers to refrain from using GemStar Infusion pumps on all Neonatal patient populations and infants up to 2 years of age, and any patients where therapy is delivered at flow rates less than 2.0mL/hour. If the GemStar device displays an X09/001 error, customers are advised to immediately remove it from clinical service and return it to Hospira for repair. Hospira is in consultation with the TGA for any further action.
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 |