| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00640-1 |
| Product Name/Description |
FreeGo Enteral Feeding Pump
Multiple REF numbers and GTIN numbers
All serial numbers
ARTG 182260
(Abbott Australasia Pty Ltd - Infusion pump, enteral feeding) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Potential for the FreeGo Pump to malfunction due to a software problem. This may lead to the pump not alarming for an occlusion, or blockage, even if an occlusion exists which could lead to no feed being delivered.
In certain patient populations, including patients at risk for hypoglycaemia or hypovolaemia, not receiving a continual source of nutrition or hydration could lead to serious adverse events including hypoglycaemia (low blood glucose), or hypovolaemia (low blood pressure). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A software update is being developed to resolve the problem and will be available in the first quarter of 2025. Customers will be notified when the software update is ready for installation.
In the interim, additional steps are to be taken by the user before the start of each feeding session or after interrupting the feed by turning the pump off and on or opening the cassette door (customers do not need to take these additional steps if the user interrupts the feed by using the hold function on the pump). More details on the additional steps are provided in the customer letter. The FreeGo pump operator manual will also be updated with these additional steps for use on priming technique. |
| Contact Information |
1800 819 831 - Abbott Pump Centre |