The event occurred in italy.It was reported that the ¿temp error¿ message occurred on the rotaflow console during use.Furthermore, it was stated that the closing assy was also broken.The device has been replaced with another one without consequences for the patient.No harm to any person has been reported.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the reported failures could be confirmed.The rfc power supply board (article number (b)(4)) and the rf drive closing cover kit (article number 701011680) has been replaced.After the replacement the device is working as intended.This closing assy is the first installed to this device in 2014 and age related aspects could be considered.The affected rfc power supply board kit (psb) (article number 701011675) was requested by the getinge field service technician for further investigation but the board is not available.This psb is the first installed to this device in 2014, age related aspects could be considered.Based on the investigation results the reported failures "temp error and closing assy broken" could be confirmed.The failure mode "temp error" can be linked to the following most possible root causes according to the rotaflow risk management file.Overtemperature condition in the device, e.G.: increased heat generation due to short circuits, heat accumulation.The reported failure "closing assy broken" was caused most probably by too excessive force, weakening due to aging (uv light (sun) or contact with chemicals).The review of the non-conformities was performed on 2024-03-12 and during the period of 2014-06-16 to 2024-02-29 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 affected rotaflow console in question was produced in 2014-06-16.In order to avoid reoccurrence of the reported failure "temp error", 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.Chapter 2.2.2 position of use and operation, and positioning make sure that the ventilation openings are not obstructed and the rotaflow system is not covered.There is a risk that the rotaflow system will overheat.Ensure a minimum distance of 50 cm to other devices, objects, or the wall.The customer will be informed about the results by the getinge sales and service unit.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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