| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00001-1 |
| Product Name/Description |
Plum 360 Infusion Pump, software version 15.02
List Number: 30010
ARTG Number: 234421 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Two software issues have been identified with the Plum 360 Infusion Pump, Software Version 15.02, namely:
Issue 1 - The pump software incorrectly generates a “Depleted Battery” alarm instead of a “Replace Battery” alarm when the battery has a near end of life charge capacity. The expected performance of the infusion pump and software is for the infusion pump to generate a “Replace Battery” alarm when the software has determined the battery has reached a near end of life charge capacity.
Issue 2 – When AC power is lost and quickly resumed, the pump software incorrectly classifies the event as an E323 alarm condition. This result in an interruption of any ongoing therapy and the infusion pump will restart (reboot). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira is advising users to connect the infusion pump to AC power and turn the pump on. They are requested to replace the battery if they see the “Replace Battery: Keep Plugged into AC! Service battery / replace pump” message. Users are also requested to replace the battery if they see the “Depleted Battery! Plug into AC now!” message while the pump is in operation. For battery replacement, users are requested to either send it to their in-house engineering department in the first instance and if further assistance is required, to contact the Hospira Service Centre.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1300 046 774 (Option 1) - Hospira |