Manufacturer's investigation conclusion: the reported events of an out of box issue and the centrimag flow probe missing its manufacturing label were not confirmed as the centrimag flow probe was not returned for analysis and no log files were submitted for review.Multiple attempts were made to obtain additional information (including if there was an out of box issue with the flow probe and if the manufacturer label was missing); however, no response was received.The root cause of the reported events could not be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.11) section 10 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual (rev.11) section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including flow related alarms, and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.
|