NOVALUNG CONSOLE (LINUX BOARD)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9, H3 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING MANUFACTURING PROCESS. FINAL INSPECTION RESULTED WITH CONFORMITY. REPAIR HISTORY OF THE CONSOLE SHOWED NO RELATED REPAIRS. THE FLOW SENSOR WAS RECEIVED FOR EVALUATION. NO EXTERNAL VISIBLE DAMAGE TO THE SENSOR WAS NOTED. THE SENSOR WAS TESTED ON A TESTING CONSOLE. NO MALFUNCTION OF THE FLOW MEASUREMENT COULD BE OBSERVED. THE FLOW MEASUREMENT WAS COMPARED WITH ANOTHER FLOW SENSOR CONNECTED TO A SECOND CONSOLE. DURING A TEST RUN OF APPROXIMATELY 14 HOURS, NO MALFUNCTION OR DEVIATION OF THE FLOW MEASUREMENT WAS OBSERVED. THE MACHINE FILES SHOWED THAT THE CONSOLE DETECTED A BACKFLOW AND ISSUED ALARM #114 WHEN A NEGATIVE FLOW WAS MEASURED. THE DATA DOES NOT INDICATE ANY MALFUNCTION OF THE CONSOLE. THE DATA SHOWED THAT AFTER ZEROING OF THE FLOW SENSOR, A NEGATIVE AND VARYING FLOW WAS MEASURED WHILE THE PUMP WAS INACTIVE OR AT ZERO RPM. IT IS POSSIBLE THAT THE SENSOR WAS ZEROED WHILE THERE WAS STILL A FLOW. REPORTEDLY, THE ISSUE RESOLVED AFTER THE FLOW SENSOR WAS REPLACED, HOWEVER, NO DEFECT OR MALFUNCTION COULD BE DETECTED IN THE FLOW SENSOR.

Description of Event or Problem

A USER FACILITY REPORTED THAT FOR SEVERAL MONTHS NOW, PERFUSIONISTS AT HENRI MONDOR HOSPITAL IN CRÉTEIL HAVE BEEN REPORTING ABOUT A BACKFLOW DETECTION PROBLEMS ON THE NOVALUNG CONSOLE, SERIAL (B)(6). THIS INCIDENT CAUSES THE PUMP TO ACCELERATE TO 10,000 RPM TO COMPENSATE FOR A FALSE BACKFLOW DETECTED ON THE CONSOLE. THE COUNTRY COMPLAINT ADMINISTRATOR RETRIEVED THE MACHINE LOG FILES CONFIRMING THE PROBLEM. UPON FOLLOW-UP, IT WAS REPORTED THIS EVENT OCCURRED ONE TO TWO TIMES DURING SUPPORT BUT WAS NOT A SYSTEMATIC ISSUE. ASSOCIATED CONSOLE ALARMS INCLUDED #114 (BACKFLOW DETECTED - ZERO FLOW ACTIVATED) AND #221 (BLOOD FLOW TOO LOW). AN EXCHANGE OF THE FLOW SENSOR ALLEVIATED THE ISSUE. IT WAS CONFIRMED THAT THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED THAT FOR SEVERAL MONTHS NOW, PERFUSIONISTS AT (B)(6) HOSPITAL IN (B)(6) HAVE BEEN REPORTING ABOUT A BACKFLOW DETECTION PROBLEMS ON THE NOVALUNG CONSOLE, SERIAL (B)(6). THIS INCIDENT CAUSES THE PUMP TO ACCELERATE TO 10,000 RPM TO COMPENSATE FOR A FALSE BACKFLOW DETECTED ON THE CONSOLE. THE COUNTRY COMPLAINT ADMINISTRATOR RETRIEVED THE MACHINE LOG FILES CONFIRMING THE PROBLEM. UPON FOLLOW-UP, IT WAS REPORTED THIS EVENT OCCURRED ONE TO TWO TIMES DURING SUPPORT BUT WAS NOT A SYSTEMATIC ISSUE. ASSOCIATED CONSOLE ALARMS INCLUDED #114 (BACKFLOW DETECTED - ZERO FLOW ACTIVATED) AND # 221 (BLOOD FLOW TOO LOW). AN EXCHANGE OF THE FLOW SENSOR ALLEVIATED THE ISSUE. IT WAS CONFIRMED THAT THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE REMAINS AVAILABLE FOR PRODUCT INVESTIGATION. HOWEVER, THE MANUFACTURER IS AWAITING RECEIPT OF THE COMPLAINT SAMPLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

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 USER FACILITY REPORTED THAT FOR SEVERAL MONTHS NOW, PERFUSIONISTS AT (B)(6) HOSPITAL IN (B)(6) HAVE BEEN REPORTING ABOUT A BACKFLOW DETECTION PROBLEMS ON THE NOVALUNG CONSOLE, SERIAL (B)(6). THIS INCIDENT CAUSES THE PUMP TO ACCELERATE TO COMPENSATE FOR A FALSE BACKFLOW DETECTED ON THE CONSOLE. THE COUNTRY COMPLAINT ADMINISTRATOR RETRIEVED THE MACHINE LOG FILES CONFIRMING THE PROBLEM. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.