The event occurred in (b)(6).It was reported that the flow rate was inaccurate on the rotaflow console during use.The device has been replaced with another one during use.No harm to any person has been reported.A getinge service technician was on site to investigate the affected rotaflow console (rfc) with s/n (b)(4) on (b)(6) 2022.The technician was unable to confirm the reported "flow rate inaccurate".During the investigation it was detected that the rfc was dusty.The device was cleaned and a functional test was performed.The device is working as intended and is back in use.Based on these investigation results the reported "flow rate inaccurate" could not be confirmed.However the failure mode "flow rate inaccurate" can be linked to the following most possible root causes according to rotaflow risk management file: dried contact gel, user forgot renewing contact gel, sensor not detected although sensor is connected, device used out of specification.The review of the non-conformities was performed on 2022-04-22 and during the period of 2019-03-26 to 2022-04-22 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow console in question was produced in 2019-03-26.In order to avoid re occurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15.6.2 reapplying ultrasonic contact cream.The ultrasonic contact cream can dry out and impair the functioning of the integrated flow/bubble sensor.In the "free" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message sig! appears.In the "stand al" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message faultbub appears.The error message sig! indicates an error in the integrated flow/bubble sensor, which may result in an incorrect flow display.The rotaflow centrifugal pump still continues to function.If the error occurs during lpm mode, the rotaflow system switches back to rpm mode automatically.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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