| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01199-1 |
| Product Name/Description |
Plum 360 Infusion Pump, with software version 15.02
List Number: 30010
ARTG Number: 234421 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Hospira has identified an issue where the User Interface (UI) does not update to reflect a calculated dose value. This only occurs when using a dosing unit in the mmol or units families. If the 1st digit entered in the Rate or VTBI field results in a calculated Dose that is less than the pump limit (0.001), the pump will dash out (“---“) the dose field & display the message ”Minimum Hard limit dose is 0.001 Press [C] key to clear entry”. This is expected behaviour. If the calculated dose is above 0.001 the pump will display the correct Dose value. The issue occurs when entering additional digits in the Rate or VTBI fields. If the Dose field is dashed out, the UI will not display the newly calculated Dose when subsequent digits are entered. Despite this, the dose value is calculated correctly; but the UI does not update to reflect the correct calculated dose value.This issue does not occur if the dose value is directly entered in the Dose field as opposed to being calculated by the pump |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hospira is providing users with work around instructions to follow as an interim measure. Users can enter the dose manually to over-ride the dash out. A software update will be implemented as a permanent correction.
This action has been closed out on 26/03/2020 |
| Contact Information |
1300 046 774 - Hospira |