NOVALUNG CONSOLE (LINUX BOARD)

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE FLOW MEASUREMENT STOPPED AND THE CONSOLE DISPLAYED ERROR #208. THE PATIENT WAS TRANSFERRED TO ANOTHER NOVALUNG CONSOLE WITHOUT COMPLICATION OR BLOOD LOSS. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9, H3 NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. THE COMPLAINT SAMPLE AND CONSOLE LOGFILES WERE RECEIVED BY XENIOS FOR PRODUCT EVALUATION. VISUAL INSPECTION AND TESTING OF THE SENSOR INTERFACE/CONNECTIONS SHOWED THAT THEY WERE CORRECTLY INSTALLED AND THERE WERE NO DEFECTS AT THE SOLDER JOINTS. ADDITIONALLY, THE SIGNALS OF THE SENSOR CONNECTION INTERFACE SHOWED CORRECT TRANSMISSION. FUNCTIONAL TESTING OF THE SENSOR BOX WAS PERFORMED IN A FOUR-DAY ENDURANCE TEST, DURING WHICH THE SENSOR BOX WAS MOUNTED ON A COMPACT HOLDER, AND NO ERRORS OCCURRED. THE REPORTED ALARM COULD NOT BE REPRODUCED DURING FUNCTIONAL TESTING.

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 DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE FLOW MEASUREMENT STOPPED AND THE CONSOLE DISPLAYED ERROR #208. THE PATIENT WAS TRANSFERRED TO ANOTHER NOVALUNG CONSOLE WITHOUT COMPLICATION OR BLOOD LOSS. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.