| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00367-1 |
| Product Name/Description |
Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use
Product Code: ALPPK1SVJ1F
ARTG Number: 274187
(Admedus Australia - Electric infusion pump administration set) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Admedus has been made aware that some users have been experiencing problems when priming the infusion lines prior to connecting them to the patient. In clinical practise, nurses will generally “prime" the lines some time before connecting to the patient. During the time between priming and connection to the patient, observations of bubbles and lost fluid have been made, even when the clamp and roller are closed. Admedus have identified that this issue is isolated to the lines containing a 0.2 micron filter when priming of the line has been performed with an inverted filter. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Admedus are advising they are providing customers with a revised Instructions for Use (IFU) which includes information on correct priming and storage of the lines.
A side clamp will be added to the distal end of the set - between the Y-site and the Luer to prevent leakage even if the operator does not follow the priming and storage instructions outlined in the IFU. Until the re-designed lines are available (expected March-May 2019), side clamps will be provided for clinicians to add on the line prior to priming.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1300 550 310 - Admedus Customer Service |