| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01251-1 |
| Product Name/Description |
Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to charge a GemStar battery pack)
List Number: 13075-XX-07 and 13075-XX-09
ARTG Number: 138118 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
1. When the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX or 13150-XX), the potential exists for the pump to fail to power up while connected to the Docking Station.
2. The second situation arises when either a GemStar Phase 3 (List 13000-XX, 13100-XX or 13150-XX) or GemStar Phase 4 pump (List 13086-XX, 13087-XX or 13088-X) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX). With this configuration, there exists a possibility that the GemStar pump will display error code 11/003 indicating excessive input voltage from the external sources. The 11/003 error code will stop infusion if the error occurs when an infusion is in process. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira is providing work around instructions to mitigate the issues. if the device fails to power up end users are advised to remove the pump from the Docking Station and then power on the pump using 2 fresh AA batteries.
To mitigate the 11/003 Error Code, end users must remove the battery pack prior to installing the pump on the docking station. If users are using a docking station in conjunction with an external battery pack accessory (List 13073), Hospira is advising that this practice should not continue. Users are advised to contact Hospira to discuss an appropriate alternative option. |
| Contact Information |
1300 046 774 - (Option 1) Hospira Customer Service |