Medical device manufacturer, Terumo Cardiovascular Systems, has issued a medical device safety alert concerning its Terumo Advanced Perfusion System 1 – Electronic Patient Gas System (EPGS) Flowmeter. The affected devices are identified as the following:
The manufacturer is initiating a voluntary field correction of the affected product because the gas flow rate output of the EPGS, which is reported in the Terumo System 1 Central Control Monitor (CCM), may be inaccurate.
Through internal investigation, the manufacturer identified that the cause of the potential inaccuracies is a defect in the EPGS internal flowmeter. Additionally, while the user may notice that the intended gas flow setpoint (slider) and the delivered gas flow reading on the CCM display do not match, there may be no other notification of the fault condition on the CCM.
The manufacturer has confirmed complaints based on EPGS flowmeter failures. All patients requiring cardiopulmonary bypass with the assistance of a Terumo System 1 with an affected EPGS flowmeter are at risk as a result of exposure to the defect or malfunction should it occur. There have been no reported illnesses or injuries as a result of this issue.
According to the manufacturer, the hazard potential depends on when the flowmeter failure occurs and the nature of the flowmeter defect. The following situations may occur: l
The manufacturer will execute a field correction to replace the affected flowmeter within the affected product and its Field Service Representative will contact users to schedule the field correction activities. Customers are advised to continue use of the device in conjunction with the backup external mechanical flowmeter found in the Terumo System 1 Accessory Kit, while waiting for this correction. Recommendations and Customer Instructions for additional information is stated in the advisory.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 26 April 2019