XLUNG KIT 230

Additional Manufacturer Narrative

CLINICAL REVIEW: A TEMPORAL RELATIONSHIP DOES NOT EXIST BETWEEN ECMO SUPPORT UTILIZING THE XLUNG KIT 230 AND THE PATIENT¿S CARDIAC ARREST LEADING TO THEIR DEATH AS ECMO COULD NOT BE INITIATED DUE TO A DE-PRIMED PATIENT CIRCUIT. THE CAUSE OF THIS PATIENT¿S CARDIAC ARREST WAS NOT REPORTED; HOWEVER, THE PATIENT¿S DEATH CAN BE ATTRIBUTED TO A POOR PROGNOSIS AND THE INABILITY TO INITIATE ECMO SUPPORT. IT IS WELL KNOWN THAT PATIENTS WHO REQUIRE ECMO SUPPORT HAVE A SIGNIFICANTLY HIGH RISK FOR MORTALITY FOLLOWING OUT-OF-HOSPITAL CARDIAC ARRESTS WITH THE NEED FOR ECMO-ASSISTED CPR (1). THE REASON FOR THE DE-PRIMED CIRCUIT AND THE INABILITY TO ESTABLISH FLOWS WAS UNKNOWN. THERE WERE NO REPORTS OF ANY LEAKS PREVIOUSLY NOTED FROM THE CIRCUIT OR VISIBLE DAMAGE TO ANY COMPONENT OF THE XLUNG KIT. AS A PRODUCT INVESTIGATION HAS NOT BEEN CONDUCTED PRIOR TO THIS REPORTING AND THE SOURCE OF THE MALFUNCTION OF THE OXYGENATOR REMAINS UNKNOWN, THE XLUNG KIT 230 CANNOT BE EXCLUDED AS A POTENTIAL SOURCE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENTS. 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 THE PATIENT CIRCUIT WAS DEAIRED DURING THE DAY WITHOUT ANY ISSUES IN PREPARATION FOR A POSSIBLE EMERGENCY. A PATIENT WAS TRANSFERRED TO THE CARDIOLOGY DEPARTMENT WHILE CARDIOPULMONARY RESUSCITATION (CPR) WAS BEING PERFORMED. THE PERFUSIONIST WAS NOT AVAILABLE TO CONNECT THE PATIENT AS SHE WAS OCCUPIED IN THE OPERATING ROOM WITH A SURGICAL PROCEDURE. THE MACHINE WAS BROUGHT DOWN WITH THE PUMP RUNNING IN ORDER TO KEEP THE CIRCUIT UNDER PRESSURE. AT THE TIME OF CONNECTING THE PATIENT, WHO WAS STILL RECEIVING CPR, THE CIRCUIT WAS FULL OF AIR, THE PUMP HEAD WAS MAKING SIGNIFICANT NOISE AND WAS UNABLE TO DELIVER AN ADEQUATE FLOW. THE PERFUSIONIST ARRIVED BUT WAS UNABLE TO INITIATE EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. AS THE FACILITY WEAS UNABLE TO CONNECT THE PATIENT, WHO WAS CANNULATED AND STILL RECEIVING CPR, THE DECISION WAS MADE TO STOP RESUSCITATION, AND THE PATIENT WAS DECLARED DECEASED. THE PUMP HEAD APPEARS TO BE DAMAGED, LIKELY BECAUSE IT WAS DE-PRIMED. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.