The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning PLUM LifeCare 5000 Series and PLUM XL Families of Infusers manufactured by Hospira Inc.The affected products are identified as follows:-

1. Plum LifeCare 5000, List number: 02507
2. Plum XL, List number :11555
3. Plum XLM, List number: 11846
4. Plum XLD, List number: 11859

The door roller assembly on the Plum A Lifecare 5000 Series and Plum XL has the potential to break which can lead to possible unrestricted flow and/or over delivery during the removal of the IV administration set's cassette from the pump.

The manufacturer is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette:

• open the cassette door by pulling on the lever;
• unlatch the cassette door by pushing on the door release tab and pulling the door down;
• visually inspect the door roller pin for any evidence of the damage or door roller misalignment; and
• ensure that the door roller spins smoothly with a finger touch. If any door rollers or pins appear loose, broken or missing, Hospira advises users to remove the device from use.

The manufacturer is in the process of retiring the Plum LifeCare 5000 and Plum XL in 2015.

For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01288-1

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 13 December 2013