| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00722-1 |
| Product Name/Description |
Alaris Infusion pump administration sets
Product Codes: 2120-0500 , 2420-0007 , 2420-0500, 10015489, 11426965
ARTG Number:125916 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
The BD Alaris Infusion pump administration sets require priming prior to use as described in the Directions for Use (DFU). BD has identified a potential issue with the BD Alaris Infusion Pump administration sets manufactured during January 2017 through March 2018. The issue pertains to the back check valve and the ability to prime the administration sets. The manufacturer has determined the root causes leading to this issue are associated with:
1. Excessive solvent used to connect the tubing to the back check valve leading to an obstruction of the fluid path, thus preventing the priming of the set.
2. A higher “cracking” pressure of the back check valve.
To date, no injuries have been reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
CareFusion is advising that users can continue to use the product.
When a set cannot be appropriately primed, users may be able to increase the pressure by gently squeezing the IV bag following these steps:
1. If no drops are observed, gently squeeze the bag at the fluid level with one hand once. Observe if set is able to prime.
2. If no drops are observed repeat this up to 3 times.
3. If this method is not effective discard and replace the administration set.
4. Consider having additional administration sets available in clinical areas where high risk infusions are administered. |
| Contact Information |
1800 833 372 - CareFusion Customer Service |