| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01162-1 |
| Product Name/Description |
Alaris GP Large Volumetric Pump (general purpose infusion pump)
Product Ref: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G
All serial numbers
ARTG number: 130389 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
CareFusion, through its Post Market Surveillance system, learned that the Alaris GP Infusion System produces very small air bubbles (less than 50ul)
which are too small to trigger the lower configurable air-in-line detection thresholds (alarm) of the Alaris GP Infusion System - being 50-500ul, as configured by the user or 1ml over a rolling 15 min. window, which is considered state of the art and in compliance with EN60601-2-24: Particular requirements for the safety of infusion pumps and controllers (according to Swissmedic). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
CareFusion is providing additional information and warnings in relation to at-risk groups of patients such as those with artial septal defect, neonates and those using multiple lines. |
| Contact Information |
02 9624 9013 - Carefusion Regulatory Affairs |