Description of Event or Problem · 0
A DEVICE MALFUNCTION WAS REPORTED FOR LIFEPORT KIDNEY TRANSPORTER (LKT101P) BY THE (B)(6). THE LKT101P WAS TRANSPORTING A RIGHT KIDNEY IN ORDER TO BE TRANSPLANTED INTO A PATIENT AT THE TRANSPLANT CENTER DESTINATION FACILITY. WHEN THE PUMP WAS HANDED OFF TO THE COURIER, IT HAD BEEN OPERATING NORMALLY. UPON ARRIVAL OF THE KIDNEY AT THE TRANSPLANT CENTER, IT WAS REPORTED THAT THE PUMP WAS NON-FUNCTIONAL. THE SURGICAL TEAM CONTACTED (B)(6) SHARING TO REPORT THAT THE PUMP WAS POWERED ON BUT NOT FUNCTIONING PROPERLY. THERE WAS NO VISIBLE DISPLAY ON THE SCREEN AND NO SIGN THAT THE PUMP WAS OPERATING. DURING A VIDEO CALL WITH THE SURGEON, (B)(6) SHARING CONFIRMED THAT BOTH LED DISPLAY DECKS WERE NONFUNCTIONAL. THE SCREENS REMAINED BLANK AND DID NOT DISPLAY ANY INFORMATION AFTER TROUBLESHOOTING. THE SURGICAL TEAM REMOVED AND TESTED THE BATTERIES, VERIFIED THEY WERE CHARGED, AND PERFORMED A RESET, BUT THE ISSUE PERSISTED. AFTER APPROXIMATELY 15¿20 MINUTES OF TROUBLESHOOTING, THE SURGEON DECIDED TO DECLINE THE KIDNEY DUE TO THE PUMP ISSUE. THE ICE COMPARTMENT WAS CONFIRMED TO BE FULL. THEREFORE, THE KIDNEY WAS CONSIDERED TO BE ADEQUATELY PRESERVED AND IN COLD STORAGE MODE. THE KIDNEY WAS REALLOCATED TO ANOTHER TRANSPLANT CENTER FOR TRANSPLANT TO ANOTHER RECIPIENT. THE DONOR KIDNEY WAS ACCEPTED BY THE SECOND TRANSPLANT CENTER. IT IS UNKNOWN IF THE DONOR KIDNEY WAS IMPLANTED AT THE SECOND TRANSPLANT CENTER. LIFEPORT KIDNEY TRANSPORTER (LKT101P) DOES NOT HAVE DIRECT PATIENT CONTACT. CONTINUOUS HYPOTHERMIC MACHINE PERFUSION OF KIDNEYS.