NOVALUNG CONSOLE (LINUX BOARD)

Description of Event or Problem

A USER FACILITY REPORTED A "# 208 NO COMMUNICATION TO FLOW BOARD ALARM" DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE USER TRIED TO RECONNECT THE FLOW SENSOR AND SENSOR BOX BUT FAILED. THE USER REPLACED THE SENSOR BOX WITH ANOTHER DEVICE WITH NO FURTHER ALARMS. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS EVENT. ACCORDING TO THE TI X 3148, THERE IS AN IMPROVEMENT ON THE FILTER BOARD FUCO-FLOW. ALTHOUGH THIS DEVICE WAS NOT IN THE AFFECTED RANGE, A TECHNICIAN TRIED TO REPLACE IT WITH THE MODIFICATION KIT VOLTAGE REGULATOR FLOW BOARD F50017611, THE # 208 ALARM WAS RESOLVED. THE COMPLAINT DEVICE WAS STILL IN USE AS OF REPORTING AND NOT AVAILABLE FOR PRODUCT INVESTIGATION. UPON FOLLOW-UP IT WAS REPORTED THE SENSOR BOX (F38350391, XCON0067) HAS NOT BEEN FIXED PREVIOUSLY AND THE COMPLAINT SEEMS TO BE RELATED TO THE CAPA FOR 206/208, FLOW SENSOR BOX ALARMS.

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

NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. THE REVIEW OF THE REPAIR HISTORY IN THE COMPLAINT SYSTEM FOR CONSOLE XEN0067 AND SENSOR BOX XCON0067 SHOWED NO REPAIR ACTIVITIES. THE REPLACED PART WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION. NO FAULTS WERE FOUND DURING THE VISUAL INSPECTION AND MEASUREMENTS OF THE OHMIC CONNECTIONS BETWEEN THE PLUG CONNECTORS. INVESTIGATION OF PREVIOUS COMPLAINTS SHOWED THAT THE ALARMS 206 AND 208 OCCUR DUE TO A FAULT IN THE POWER SUPPLY TO A CIRCUIT BOARD WITHIN THE SENSOR BOX. CONTACT PROBLEMS BETWEEN THE DIGIFLOW MINI1 BOARD AND THE FUNCTION CONTROLLER BOARD (FUCO) MIGHT HAVE CAUSED AN INSUFFICIENT VOLTAGE SUPPLY OF THE DIGIFLOW MINI1 BOARD. THE SENSOR BOX HAS BEEN MANUFACTURED WITH CABLE D500-0187CB WITH GOLD CONTACTS, WHICH RESOLVED THE RISK OF FRETTING AND GALVANIC CORROSION AT THE CONNECTION TO THE DIGIFLOW MINI1 BOARD DUE TO MIXED MATERIALS (TIN / GOLD CONTACT). THE DEVICE WAS THEREFORE NOT INCLUDED IN LIST OF AFFECTED DEVICES FOR THE IMPROVEMENT. INVESTIGATION OF THE RETURNED CABLE HARNESS CONNECTING THE TWO BOARDS REVEALED NO DEFECT AT THE COMPONENT. THE MOST LIKELY CAUSE OF THE EVENT IS A LOOSE CONTACT ON ONE OF THE CONNECTIONS TO THE CIRCUIT BOARDS. THE CONNECTION OF THE CIRCUIT BOARDS HAS BEEN CHANGED TO STABILIZE THE VOLTAGE SUPPLY OF THE DIGIFLOW MINI1 BOARD PER A PREVIOUSLY IMPLEMENTED CAPA.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9, H3 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. THE REVIEW OF THE REPAIR HISTORY IN THE COMPLAINT SYSTEM FOR CONSOLE XEN0067 AND SENSOR BOX XCON0067 SHOWED NO REPAIR ACTIVITIES. INVESTIGATION OF PREVIOUS COMPLAINTS SHOWED THAT THE ALARMS 206 AND 208 OCCUR DUE TO A FAULT IN THE POWER SUPPLY TO A CIRCUIT BOARD WITHIN THE SENSOR BOX. CONTACT PROBLEMS BETWEEN THE DIGIFLOW MINI1 BOARD AND THE FUNCTION CONTROLLER BOARD (FUCO) MIGHT HAVE CAUSED AN INSUFFICIENT VOLTAGE SUPPLY OF THE DIGIFLOW MINI1 BOARD. THE SENSOR BOX HAS BEEN MANUFACTURED WITH CABLE D500-0187CB WITH GOLD CONTACTS, WHICH RESOLVED THE RISK OF FRETTING AND GALVANIC CORROSION AT THE CONNECTION TO THE DIGIFLOW MINI1 BOARD DUE TO MIXED MATERIALS (TIN / GOLD CONTACT). THE DEVICE WAS THEREFORE NOT INCLUDED IN LIST OF AFFECTED DEVICES FOR THE IMPROVEMENT. INVESTIGATION OF THE RETURNED CABLE HARNESS CONNECTING THE TWO BOARDS REVEALED NO DEFECT AT THE COMPONENT. THE MOST LIKELY CAUSE OF THE EVENT IS A LOOSE CONTACT ON ONE OF THE CONNECTIONS TO THE CIRCUIT BOARDS. THE CONNECTION OF THE CIRCUIT BOARDS HAS BEEN CHANGED TO STABILIZE THE VOLTAGE SUPPLY OF THE DIGIFLOW MINI1 BOARD PER A PREVIOUSLY IMPLEMENTED CAPA.