| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00245-1 |
| 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 |
11/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Leakage from the AA Battery causes a barrier to the power contacts resulting in no power being delivered, and in some instances the leakage results in contamination or corrosion of the power circuitry. Excessive voltage ingress (voltage from the outside AC power adapter) to voltage regulators can cause them to fail. Failure of these regulators may result in the device shutting off without issuing a warning or an audible or visual alarm. If the device shuts off it will result in a delay/interruption in therapy. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
As directed by the Gemstar Technical Service Manual (TSM), the internal AA batteries and battery compartment should be inspected for signs of leakage, corrosion or other damage prior to each use. In addition, each time the batteries are replaced the battery compartment should be inspected for damage.
If a device exhibits damage caused by leaking batteries, immediately remove it from clinical service and return it to Hospira for repair.
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 046 771 OPTION 1 - Hospira Customer Service |