NOVALUNG CONSOLE (LINUX BOARD)

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A CLINICAL SUPPORT SPECIALIST (CSS) ASSISTED A USER FACILITY PRIMARY PERFUSIONIST WITH THE PROCESS OF SWITCHING TO THE BACKUP PUMP DRIVE AND THEY WERE ABLE TO DO SO SUCCESSFULLY. THE PATIENT REMAINED STABLE DURING THE PROCESS. DURING THE CONVERSATION, THE CSS HEARD ANOTHER PERFUSIONIST ASK, "WHAT IS THE PURPOSE OF HAVING THESE CABLES PLUGGED INTO THE BACK OF THE CONSOLE?" THE CSS EXPLAINED THAT WAS THE POWER SOURCE FOR THE SENSOR BOX AS WELL AS THE PUMP DRIVE. THE CSS ASKED THE PRIMARY PERFUSIONIST TO SEND A SCREEN SHOT OF THE ALARM HISTORY SCREEN, WHICH REVEALED MULTIPLE ALARMS INDICATING THE SENSOR BOX HAD BEEN UNPLUGGED AND THE PUMP DRIVE HAD BEEN UNPLUGGED. (TECHNICAL FAILURE PUMP DRIVE #00A, TECH. FAILURE SENSOR BOX #008). THESE TWO ALARMS OCCURRED SEVERAL TIMES CONCURRENTLY PER THE ALARM HISTORY. IT WAS EXPLAINED THAT THE CABLES NEEDED TO BE PLUGGED IN WHICH ELIMINATED THE ERROR MESSAGES AND PUMP STOPPAGES. THE DEVICE IN QUESTION HAD BEEN PM'S EARLIER THIS YEAR. NO COMPONENT OF THE CONSOLE WILL BE RETURNED FOR PRODUCT INVESTIGATION.