It was reported that the flow/bubble sensor (flow probe) quit reading during treatment.No harm to any person has been reported.A getinge technician was sent for investigation on 2021-10-01.He could not confirm the failure and the device was put back in use.The log files also shows no malfunction of the device.Therefore, the reported failure "flow/bubble sensor (flow probe) quit reading" could not be confirmed.An exact root cause could not be identified.However, with reference to the current risk file the following most possible causes could be linked to the reported failure: wrong bubble sensor information; influence due to other ultrasonic devices (e.G.Flow sensor); connection of non-capatible sensor; environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage); bubble sensor cannot be plugged.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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