| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00247-1 |
| 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 |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The proximal and distal pressure sensor calibration can drift resulting in late or missed or false occlusion alarms or reporting of one of the following errors during device setup or infusion:
- Cassette Check – D
- Cassette Check – P
- Proximal Occlusion
- Distal Occlusion
- Pressure Calibration Error
- Bad Pressure Sensor Event
- Bad Pressure Sensor State
- Distal Pressure is Out of Range
- Proximal Sensor is Out of Range |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira recommends customers to review the GemStar maintenance schedule and confirm that the Operation test (which includes specific tests for proximal and distal occlusion) is being performed at least on an annual basis. If a device fails either of the proximal or distal occlusion tests at any time immediately remove it from clinical service and return it to and return it to Hospira for repair. Hospira is in consultation with 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 |