NOVALUNG CONSOLE (LINUX BOARD)

Additional Manufacturer Narrative

PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS OF THE PUMP DRIVE. FINAL INSPECTION RESULTED IN CONFORMITY. NO COMPONENTS WERE RETURNED FOR EVALUATION; HOWEVER, NINE LOGFILES WERE PROVIDED BY THE INITIAL REPORTER. THE LOG DATA SHOWS TWO PROBLEMS: A BLOCKED DRIVE AND FAULTS IN THE CONNECTION TO THE DRIVE. MEANING OF THE ALARMS: #00A: THE CONTROL PANEL HAS NO COMMUNICATION WITH THE DRIVE; #10B: SPEED DEVIATION DURING DRIVE SELF-TEST (WHEN SWITCHING ON); #103: DRIVE SPEED DEVIATION DURING OPERATION IS NOT INCLUDED IN THE LOG FILE; #211: FLOW SIGNAL (ULTRASONIC ECHO) TOO WEAK (A LOT OF AIR OR NO LIQUID IN THE TUBING OR SENSOR NOT CONNECTED TO THE TUBING). THE CONNECTION TO THE DRIVE APPEARS TO BE FAULTY AND ALARM #00A KEEPS COMING AND GOING. IN ADDITION, ALARM #10B IS ALSO REPORTED AS SOON AS THE CONNECTION IS ACKNOWLEDGED (I.E. 00A IS GONE). AT 16:25:43 THE DATA SHOWS A DOCUMENTED START-UP OF THE DRIVE WHICH IS ERROR-FREE AND FROM THIS MOMENT ON, THE DRIVE RUNS ERROR-FREE. ALARM #00A ONLY OCCURS AGAIN VERY SHORTLY BEFORE THE SHUTDOWN. IT IS UNKNOWN WHAT EXACTLY CAUSED THE CONNECTION PROBLEM (00A) OF THE PUMP DRIVE AT THE BEGINNING. POSSIBLY THE PUMP DRIVE WAS NOT PLUGGED IN CORRECTLY. ALSO, THE CAUSE FOR THE SPEED DEVIATION DURING SELF-TEST (10B) IS UNKNOWN. IT IS NOT POSSIBLE TO SAY WHETHER THE TWO THINGS ARE CONNECTED. ACCORDING TO THE XENIOS FIELD TECHNICIAN, THE PUMP DRIVE WAS REPAIRED. THE MOTOR HAD TO BE REPLACED BECAUSE IT WAS NOT TURNING.

Description of Event or Problem

AN ACCOUNT MANAGER REPORTED THAT DURING SETUP AND PRIMING OF THE NOVALUNG CONSOLE, THE USER ATTEMPTED TO INCREASE THE RPMS TO FULLY PRIME THE CIRCUIT. THE USER NOTED A "PUMP ERROR" ALARM ON THE PUMP DRIVE WITH MULTIPLE ALARMS ON THE CONSOLE TO INCLUDE #00A, #211, #103 AND #10B. THERE WAS NO FORWARD FLOW NOTED TO THE PUMP HEAD AND THE FLOW SENSOR READ NEGATIVE FLOWS. THE PUMP HEAD WAS UNPLUGGED, THE DEVICE TURNED OFF AND ON WHICH RESULTED IN THE SAME "PUMP DRIVE ERROR." THE PUMP DRIVE WAS EVENTUALLY EXCHANGED WITH NO ISSUE. THE SAME PUMP DRIVE WAS USED ON A DIFFERENT CONSOLE WHICH RESULTED IN THE SAME ERROR. THE EVENT OCCURRED DURING A DEMONSTRATION AND THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION AS THE DEVICE WILL BE REPAIRED ONSITE.

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

AN ACCOUNT MANAGER REPORTED THAT DURING SETUP AND PRIMING OF THE NOVALUNG CONSOLE, THE USER ATTEMPTED TO INCREASE THE RPMS TO FULLY PRIME THE CIRCUIT. THE USER NOTED A "PUMP ERROR" ALARM ON THE PUMP DRIVE WITH MULTIPLE ALARMS ON THE CONSOLE TO INCLUDE #00A, #211, #103 AND #10B. THERE WAS NO FORWARD FLOW NOTED TO THE PUMP HEAD AND THE FLOW SENSOR READ NEGATIVE FLOWS. THE PUMP HEAD WAS UNPLUGGED, THE DEVICE TURNED OFF AND ON WHICH RESULTED IN THE SAME "PUMP DRIVE ERROR." THE PUMP DRIVE WAS EVENTUALLY EXCHANGED WITH NO ISSUE. THE SAME PUMP DRIVE WAS USED ON A DIFFERENT CONSOLE WHICH RESULTED IN THE THE SAME ERROR. THE EVENT OCCURRED DURING A DEMONSTRATION AND THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION AS THE DEVICE WILL BE REPAIRED ONSITE.