Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-01039-1 |
Product Name/Description |
Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infusion pump)
Plum A+ Pump Version 11.6 Catalogue number 611239101 Number on pump: 12391/11971
Plum A+ Pump Version 13.4 Med Net ABG Driver Catalogue number: 612079201 Number on pump 20792
ARTG Number: 138109 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
11/10/2012 |
Responsible Entity |
|
Reason/Issue |
The volume control knob located on the back of the infuser may not function as described in the System Operating Manual; the direction for loud and quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume, however on some devices the alarm volume increases when the knob is turned clockwise. While the device will continue to alarm with an audible tone of at least 50dBA at the lowest level, inadvertently setting a low tone may result in an audible alarm that is more difficult to hear. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Hospira is providing work around instructions and will be updating the Instructions for Use (IFU). |
Contact Information |
1300 046 774 - OPTION 1, Hospira Customer Service |