| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00721-1 |
| Product Name/Description |
Drager Ventstar Paediatric Circuit, used in conjunction with the Dräger Oxylog 3000plus Transport Ventilator
ARTG Number: 131796 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
During the course of routine internal testing Drager detected isolated leakages at the check valve (one way valve of the inspiration branch) of the above mentioned disposable paediatric ventilation circuit. Leakage at the check valve can result in a patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the exhaled gas with subsequent reduced oxygen concentration for the patient. This leakage is not detected during the ventilator operational readiness check. To date, Drager has not received any complaints associated with this issue.
Further detailed investigations have shown that the check valve functions properly with no leak observed at positive end-expiratory pressures above 5 mbar I cmH20. The problem only occurs at PEEP values below 5 mbar I cmH20. |
| Recall Action |
Recall |
| Recall Action Instructions |
Drager urgently recommends that users immediately inspect any stock and dispose of any product (part number 5704964) with a date of manufacture up to and including 03-2016. A Free of charge replacement product can be obtained by following the instructions in the customer letter.
This action has been closed-out on 22/03/2018. |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |