Description of Event or Problem · 0
THIS EVENT IS BEING REPORTED TO THE FDA AS A PART OF PROACTIVE QUALITY PLAN UNDERTAKEN BY TRANSMEDICS INC. THE REPORTABLE MALFUNCTIONS UNDER THIS QUALITY PLAN REPRESENT <0.2% OF ALL OCS TRANSPLANTS. IN THIS CASE, DURING INSTALLATION OF THE MODULE, THE USER MADE AN ERROR AND INSTALLED IT WHEN THE SYSTEM WAS ALREADY IN RUN MODE, INSTEAD OF IN STANDBY MODE. AFTER THE HEART WAS INSTRUMENTED ON THE OCS SYSTEM, THE USER COULD NOT ACTIVATE AUTO MODE FOR THE SDS MODULE, AND THEY WERE NOT ABLE TO SHOCK THE HEART WITH THE ELECTRODE PADS. THEY USED EXTERNAL PADS BUT IT WAS REPORTED THAT THE HEART WAS PERSISTENTLY ON VF. TROUBLESHOOTING ATTEMPTS WERE CONDUCTED WITHOUT SUCCESS. THE DONOR HEART WAS DECLINED AFTER 20 MINUTES OF TROUBLESHOOTING ATTEMPTS AS THE RECIPIENT SURGEON WAS CONCERNED ABOUT POTENTIAL ISCHEMIA. THE OCS CONSOLE SESSION FILES WERE ANALYZED. THE REPORTED CONDITIONS THAT THE SYSTEM WAS UNABLE TO USE AUTO MODE FOR THE SDS MODULE AND THAT THE ECG PADS DIDN'T SHOCK WERE CONFIRMED. THE CAUSE OF THESE ISSUES CAN BE TRACED TO THE FACT THAT THE CONSOLE DIDN'T RECOGNIZE THAT A PERFUSION MODULE WAS INSTALLED. THE REASON WHY THE PERFUSION MODULE WASN'T RECOGNIZED BY THE CONSOLE COULD NOT BE DETERMINED, SINCE THE RETURNED MODULE HAD LIQUID DAMAGE AND COULD NOT BE TESTED ELECTRICALLY.