| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01312-1 |
| Product Name/Description |
Alaris System Pump module (LVP), Mechanism Sub-assembly and Kit Assembly
Alaris System Pump module (LVP) 8100 manufactured between 4 November 2011 and 11 March 2012
Alaris Pump module LVP Mechanism Sub Assembly manufactured by the supplier between 4 November 2011 and 14 March 2012
Part Number: 10942012
Alaris Pump module Bezel Kit Assembly manufactured by the supplier between 4 November 2011 and 26 March 2012
Part Number: 10964559
ARTG Number: 146664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Becton Dickinson (BD) has identified an issue with the Alaris pump module regarding increased or decreased flow rates that have occurred in pumps with mechanical assemblies manufactured between November 2011 and March 2012.
The component of the Alaris pump module causing this issue is the bezel assembly, specifically the bezel posts. The affected posts may have cracking in one or more posts that connect the mechanism frame to the bezel assembly. Separation of one or more bezel posts may prevent the device from delivering an accurate amount of fluid through the pumping cycle, resulting in an over or under infusion.
Zero reports relating to this issue have been received in Australia |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
BD has assessed the risk of this issue and determined that the affected product can still be used until this correction is carried out. However, BD strongly recommends that clinicians increase their level of vigilance when using impacted pumps. Additionally, clinicians should remove the pump from service if it shows signs of infusion at an unexpected rate. Use non-affected, or remediated, devices in high risk areas if possible. In addition, to the best of BD’s ability, BD will work with customers to identify and mark individual pumps that have not yet been remediated.
BD will replace the mechanical assembly of the affected serial numbers at no charge. BD will be in contact with all affected customers to initiate the scheduling process for the remediation.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 8875 7250 - CareFusion |