The event occurred in germany.It was reported that the rubber feet and the battery cover of the rotaflow are damaged.In addition the rotaflow displays the error message ¿run-away¿.The failures were discovered during the maintenance of the device.No patient has been involved when the failure occurred.No harm to any person has been reported.The affected rotaflow console with (b)(6) was investigated by a getinge field service technician and the reported failures "battery cover broke and rubber feet damaged and also the error message "run-away" could be confirmed.The hl20_rubber foot 24x12 rpm/tpm (article number 70105.4567) the rfc (rotaflow console) flow measure board (article number 70101.1681) and the rf battery cover (article number70107.3414) has been replaced.A functional check of the device was performed and is back in use.The affected rfc flow measure board (material#70101.1681) was send back to the manufacturer for investigation.The part was investigated by the getinge life-cycle-engineering (lce).A rotaflow flow measuring board was under investigation following a complaint regarding the error message ¿run-away¿ in the lpm-mode during the preventive maintenance.The reported failure ¿run-away¿ could be reproduced during the investigation when the lpm-mode is activated at a speed below 1500rpm (revolutions per minute) if the zero flow calibration has not been performed as required by the ifu (instruction for use).The probable root cause could be determined as a defective signal processor mo1 which can lead to this message.The most probable root cause for the damaged (porous, hard and cracked) feet could be environmental influences (e.G cleaning agents) or due to aging of the device according to our technical support.The affected rotaflow console was produced in 2008.The most probable root cause for the "battery cover broke" could be determined as rough handling by the customer.Based on the investigation results the reported failures "battery cover broke / rubber feet damaged and the error message "run-away" could be confirmed.The review of the non-conformities has been performed on 2022-10-31 for the period of 2008-05-01 to 2022-10-26.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 product in question was produced in 2008-05-01.In order to avoid reoccurrence of the reported failure error "run-away", 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 | 15.5.5 calibration.To achieve the specified flow accuracy, calibrate the flow sensor, check ist functionality before each application and define the current blood temperature range.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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