This medwatch is being filed to relay additional information.Reported issue: the cart was not registering fluid levels properly.Device evaluations results/investigation findings: review of the most recent repair records determined the unit had not been processed properly preventing the level sensors to be reset.The technician informed the user the wash cycle must be completed to reset level sensor.The unit was tested and returned to service without issue.Root cause: the level sensor is required to read and report fluid level in the cylinders in order for the unit to function as intended.Design-related failure modes: a clog due to biomaterial or a foreign object will cause a blockage in the cylinder and impaired use of the drain; this failure will cause inaccurate readings from the level sensor, as the residual fluid unable to drain may not be accurately accounted for by the component.Mechanical failure from loosening can occur as the level sensor is mounted in the base of the cart with an o-ring and held in place with two setscrews.Over time and through continuous use, the screws can loosen, allowing the sensor rod to move within the cylinder and prompting errors.The level sensor float can fail through continuous use and wear as well.Bioburden can build up on the level sensor float or magnet, or the level sensor float could crack, both failure modes can disrupt the buoyancy of the float, causing incorrect fluid level readings.Application-based failure modes: tandem and range errors occur due to user error.Tandem errors populate when the device¿s software detects an incorrect fluid level measurement in one or both cylinders often when the user introduces fluid into the cylinder after the pump has shut off due to the cylinder being full.Tandem errors are a result of fluid levels increasing without the vacuum system being turned on.Due to a range of external (non-design / non-manufacturing related) variables potentially impacting the component, identifying definitive causes for each level sensor failure is generally not possible.
|