User reports "head error" message on the hl 20 during priming.No harm to any person was reported.A getinge field service technician was onsite and investigated the unit in question.The hl 20 roller pump module was checked and all connections were reset.The pump was observed for one hour and no problem was found.The technician also checked alle the other pumps on the hl20 console.All pumps work to factory specification.Thus the reported failure could not be confirmed.However the failure mode "head error" can be linked to the following most possible root causes according to the hl 20 risk management file ((b)(4) version 11): failure of pump control board, defective/ dirty tacho, relay or pump belt.Device was manufactured in 2016-05-20.The review of the non-conformities during the period of 2016-05-20 to 2022-04-28 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 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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