Medical device manufacturer, Draeger Medical GmbH, has issued a medical device safety alert concerning its disposable paediatric ventilation circuit VentStar Oxylog 3000F (P) 190 [Part number: 5704964; date of manufacture: up to 03-2016] for Oxylog 3000 and Oxylog 3000 plus transport ventilators.
During the course of routine internal testing, the manufacturer detected isolated leakages at the check valve (one way valve of the inspiration branch) of the affected device. Further detailed investigations have shown that the check valve functions properly with no leak observed at positive end-expiratory pressures above 5 mbar / cmH2O. The problem only occurs at PEEP values below 5 mbar / cm H2O.
According to the manufacturer, leakage at the check valve can result in patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the exhaled gas with reduced oxygen concentration for the patient.
The manufacturer recommends that the users immediately inspect any stock and dispose of any product (part number 5704964) with a date of manufacture up to and including 03-2016. If it is necessary to use affected ventilation circuits prior to receiving replacements, the manufacturer recommends only using the circuit at a PEEP setting of > 5 mbar / cmH2O, provided that a PEEP setting of > 5 mbar / cmH2O is appropriate from a medical point of view. Additionally, the manufacturer recommends for this use case the use of external CO2 monitoring by means of a paediatric cuvette and CO2 mainstream sensor.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 26 May 2016