The initial failure description was that the rotaflow displays the error message "error com".The failure occurred during patient treatment and has been exchanged with a backup device.No harm to any person occurred.A getinge service technician was on site on 2022-01-15 to repair the affected rotaflow (serial#(b)(6)).The technician confirmed the reported failure and replaced the rfc (rotaflow console) control board kit (material#70103.4051).After the replacement the device is working as intended.The affected rfc (rotaflow console) control board kit (material#70103.4051) is not available.Based on these investigation results the reported failure could be confirmed.The failure mode "com error" can be linked to the following most possible root causes according to our risk management file.Malfunction of the microcomputer system: 1.Internal cpu failure; 2.Failure on other device parts (rotary knob, display, etc); 3.Failure of internal components (adc, etc.).The product in question was produced in 2015-09-01.The review of the non-conformities has been performed on 2022-02-01 for the period of 2015-09-01 to 2021-12-25.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.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.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.
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