Medical device manufacturer, Terumo Cardiovascular, has issued a medical device safety alert concerning its Terumo Advanced Perfusion System 1 – Electronic Patient Gas System (EPGS) [Catalog Number: 801188; Lot Number or Serial Number Range: S/N - 01751]
The manufacturer has identified an intermittent failure in the affected device, which could cause a blender initialisation fault upon start-up or during an EPGS calibration attempt following the 15-minute warm-up period. The device was assembled with stepper motors that did not meet supplier specifications. System diagnostics recognises the fault condition and posts an error message for the user “Gas System: Knob Adjust Only” at which time the gas system flow and FiO2 control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs.
According to the manufacturer, there have been no reported illnesses or injuries due to this issue. For the fault condition, the mitigation guidance provided by the messaging on the System 1 CCM and that detailed in the Terumo Advanced Perfusion System 1 Operators Manual will enable the continued use of the EPGS without interruption and without compromise of patient safety.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Jun 2021