The event occurred in japan.It was reported that during clinical use of the rotaflow console and drive the error message "head error" occurred and the pump stopped.The rotaflow console and drive has been replaced with no consequences for the patient.No harm to any person has been reported.A getinge service technician was on site to investigate the affected rotaflow console with s/n (b)(6) and the rotaflow drive with s/n (b)(6).The technician was able to confirm the reported "head error".During the investigation by the technician a worn out lemo master connector was detected which lead to a interrupted communication between the rotaflow console and drive.The connection cable rf drive socket (article number 701034666) has been replaced.After the replacement the device is working as intended.The following most possible root cause for the reported "head error" could be determined as a worn out lemo master connector which lead to an interrupted communication between the rotaflow console and drive which caused the "head error".Based on these investigation results the reported "head error" could be confirmed.Rotaflow console s/n (b)(6) the review of the non-conformities was performed on (b)(6) 2022 and during the period from (b)(6) 2012 to (b)(6) 2022 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 was produced (b)(6) 2012.Rotaflow drive s/n 91063913 the review of the non-conformities was performed on (b)(6) 2022 and during the period from (b)(6) 2012 to (b)(6) 2022 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 drive was produced 2012-10-01.In order to avoid reoccurrence 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.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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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