It was reported that a negative flow on the venous side was noted.No information regarding the hls set were provided by the customer.In addition the hls set was not available for technical investigation.A getinge service technician investigated the involved cardiohelp unit on (b)(6) 2022 and no failure or malfunction was noted.The technician performed safety, calibration, and functionality checks to factory specifications.As determined in the hls set risk assessment following probable root causes can lead to the reported event: hls is positioned above patient.Negative pressure on the blood side.Negative pressure in the venous system.Based on the investigation results no product related malfunction could be confirmed.The customer will be made aware of the investigation results.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.H3 other text : 4115.
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