| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01335-1 |
| Product Name/Description |
Plum 360 Infusion System
Software version: 15.10.00.010
List Number: 30010
ARTG Number: 234421 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Two issues have been identified with the Plum 360 Infusion System involving the Distal Occlusion Auto Restart (DOAR) feature and Preventative Maintenance (PM) Due Notification.
Issue 1 - If the DOAR feature is enabled and a Distal Occlusion occurs, the pump will be in a "paused" state. If a malfunction alarm occurs while the pump is in the paused state waiting for the distal pressure to decrease, the pump cannot be turned off nor delivery restarted until the battery is discharged or disconnected. Once the battery is recharged or reconnected, the pump can be returned to clinical service.
Issue 2 - When the PM screen is accessed from the main Biomed Settings menu on pumps that have accumulated a Total Delivery Time greater than 1500 hours, the user will not be able to interact with the pump and the pump must be power cycled. Once this is done, the pump can be returned to clinical service.
There have been no reports of a serious injury or death related to these issues. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
For Issue 1: Hospira is providing work around instructions for users to follow as a interim measure.
For Issue 2: Hospira is advising users to not enable the optional Preventative Maintenance Due Notification feature.
A software update will be implemented as a permanent correction.
This action has been closed out on the 22/10/2018.
This action has been closed out on 11/09/2019 |
| Contact Information |
02 8335 1010 - ICU Medical Service Department |