NOVALUNG CONSOLE (LINUX BOARD)

Additional Manufacturer Narrative

CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN ECMO SUPPORT UTILIZING THE NOVALUNG CONSOLE AND THE PATIENT¿S NEED FOR CONTINUED RESUSCITATION EFFORTS. THE NEED FOR CONTINUED CPR WAS PREDICATED ON THE PATIENT¿S CRITICALLY ILL CONDITION PRIOR TO ECMO SUPPORT. THOUGH SUPPORT WAS INTERRUPTED AND BRIEFLY DELAYED, THE INCIDENT ON THE CONSOLE WAS NOT THE CAUSATIVE FACTOR IN THE PATIENT¿S CARDIOGENIC SHOCK, NOR DID IT EXACERBATE THE PATIENT¿S CONDITION. IT IS WELL ESTABLISHED THAT CRITICALLY ILL PATIENTS ON ECMO SUPPORT CARRY A HIGH RISK OF MORBIDITY DUE TO UNDERLYING PATHOLOGY AND/OR THE PATIENT¿S RESPONSE TO ECMO SUPPORT. IT CAN BE CONCLUDED THAT THE NEED FOR CPR WAS BASED ON THE PATIENT¿S CRITICAL CONDITION. THEREFORE, THE NOVALUNG CONSOLE CAN BE EXCLUDED AS A CAUSE OF THIS PATIENT¿S ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO ALLEGATION OR OBJECTIVE EVIDENCE OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) DEFICIENCY OR MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THIS PATIENT¿S ADVERSE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE RELATED TO ANY FRESENIUS DEVICE(S) AND/OR PRODUCT(S), PLEASE RESUBMIT FOR A CLINICAL REVIEW AND THE NEED FOR A CLINICAL INVESTIGATION WILL BE REASSESSED ACCORDINGLY. 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 AFTER STARTING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE CONSOLE COULD NOT BE CONTROLLED. THE CONSOLE SHOWED ¿ERROR SENSOR BOX¿, ¿ERROR POWER SUPPLY¿ AND ¿ERROR PUMP DRIVE¿. THE USER ALSO COULD NOT SHUT DOWN THE CONSOLE. AFTER INITIALIZING VENO-ARTERIAL ECMO SUPPORT FOR A PATIENT WHO PREVIOUSLY EXPERIENCED CARDIOGENIC SHOCK, THE CONSOLE BECAME UNCONTROLLABLE (TECHNICAL FAULT PS, SB AND PD; #007, #008 AND #00A). THE PATIENT HAD TO BE RESUSCITATED AS CAN BE EXPECTED FROM A PATIENT IN CARDIOGENIC SHOCK PRIOR TO SUPPORT. AFTER THE PATIENT WAS TRANSITIONED TO A SECOND XENIOS CONSOLE, THE PATIENT STABILIZED. UPON FOLLOW-UP, IT WAS REPORTED THAT ACCORDING TO MACHINE LOG DATA, THE 'CAN' CONNECTION BETWEEN THE CONTROL PANEL AND THE POWER SUPPLY WAS INTERRUPTED; HOWEVER, THE FAILURE COULD NOT BE REPRODUCED BY TECHNICAL SERVICES ONSITE AND NO DEFECT WAS FOUND. REGARDLESS, THE SERVICE TECHNICIAN REPLACED THE CONNECTION CABLE AND THE PLUG ONSITE. NO COMPONENT OF THE CONSOLE WILL BE RETURNED FOR PRODUCT EVALUATION.