Description of Event or Problem · 0
THE RIGHT KIDNEY WAS PLACED ON PUMP ON (B)(6) AT 4:25AM. THE COURIER PICKED UP THE RIGHT KIDNEY FOR TRANSPORT ON (B)(6) AT 7:29AM. THERE WERE NO ISSUES WITH THE PUMP'S FUNCTION PRIOR TO COLLECTION BY THE COURIER. THE PUMP WAS OPERATING NORMALLY FOR OVER 3 HOURS PRIOR TO HANDING IT OFF TO THE COURIER FOR DELIVERY. THE PUMP'S LAST READINGS PRIOR TO HANDOFF WERE: RESISTANCE: 0.08MMHG; FLOW: 115ML/MIN; PRESSURE: 16MMHG; AND TEMPERATURE: 2.8°C. (B)(4) ONLY COMMUNICATED PICK-UP AND DELIVERY INSTRUCTIONS TO THE COURIER; NO ADDITIONAL COMMUNICATIONS REGARDING THE STATE OF THE PUMP WERE MADE. THE RIGHT KIDNEY WAS DELIVERED TO THE ACCEPTING PROGRAM ON (B)(6) @ 10:41AM. ON (B)(6) AT 11:15 AM, OUR MANAGER OF SURGICAL SERVICES ((B)(6)) RECEIVED NOTICE OF THE PUMP'S MALFUNCTION FROM THE ACCEPTING PHYSICIAN. (B)(6) CONNECTED ON A VIDEO CALL WITH THE ACCEPTING PHYSICIAN TO UNDERSTAND AND ASSIST IN TROUBLESHOOTING THE MALFUNCTION. UNDER (B)(6) INSTRUCTIONS, THE ACCEPTING CENTER ATTEMPTED TO RESOLVE THE PUMP ISSUE BY REMOVING AND REINSTALLING ALL PUMP BATTERIES, CHECKING FOR CORRECT BATTERY ALIGNMENT, TESTING THE STOP/PRIME/INFUSE FUNCTIONS, AND PERFORMING A HARD RESET OF THE PUMP. UNFORTUNATELY, THE PUMP COULD ONLY ENTER PRIME MODE WITH BLANK LED (LIGHT-EMITTING DIODE) SCREENS AND UNABLE TO DISPLAY ANY OPERATIONAL DATA. AFTER APPROXIMATELY 15-20 MINUTES OF TROUBLESHOOTING, THE ACCEPTING SURGEON DECIDED TO DECLINE THE KIDNEY DUE TO THESE PUMP ISSUES. THE ICE COMPARTMENT WAS CONFIRMED TO BE FULL, AND BASED ON MANUFACTURER GUIDELINES, WELL WITHIN THE 10 HOURS OF VALIDATED COLD STORAGE. A COURIER WAS THEN DISPATCHED TO RETURN THE PUMP AND KIDNEY TO (B)(4). WHILE EN-ROUTE FOR PICKUP, (B)(6)) CALL WAS INFORMED OF THE SITUATION, ACKNOWLEDGED THE TRANSITION TO STATIC COLD STORAGE, AND ACCEPTED THE KIDNEY WITHOUT REQUIRING RETURN TO THE (B)(4). THE COURIER WAS REROUTED TO CALL ACCORDINGLY, WITH PICKUP AT 12:52PM AND DELIVERY TO CALL AT 14:39PM. UPON THE PUMP'S EVENTUAL RETURN TO THE (B)(4) OFFICE, THE PUMP WAS TAKEN OUT OF SERVICE, THE DEVICE MANUFACTURER WAS NOTIFIED OF THE ISSUE AND SERVICING WAS REQUESTED PRIOR TO ANY FUTURE USE. WHILE MARKED OUT OF SERVICE, WE INSPECTED THE PUMP FURTHER. WE TESTED ALL BATTERIES (4) -- THREE DISPLAYED FULL CHARGE LEVELS AND ONE SHOWED LOW CHARGE. PER THE MANUFACTURER, THESE PUMPS WILL FUNCTION ON ONE BATTERY AT A TIME, IN SEQUENTIAL ORDER, UNTIL ALL BATTERIES ARE DRAINED. THE PUMPS ARE VALIDATED TO RUN FOR 40+ HOURS OFF A FULL 4-BATTERY CHARGE. WHEN CONNECTED TO A WALLED POWER-OUTLET, ICED, AND WITH A TRAINING CASSETTE, THE PUMP FUNCTIONED NORMALLY AND THE PRIOR MALFUNCTION EXPERIENCED DURING THE CASE COULD NOT BE REPLICATED. THIS PUMP WAS ULTIMATELY SENT BACK TO THE MANUFACTURER FOR FURTHER EVALUATION ON (B)(6). WE AWAIT TO HEAR FROM THE MANUFACTURER AS TO THE CAUSE OF THIS PUMP'S FAILURE. WE BELIEVE THE ROOT CAUSE OF THIS EVENT TO BE DUE TO A FAULT IN THE FUNCTION OF THE ACTUAL MEDICAL DEVICE. AS OF TODAY, (B)(4) HAS NOT IMPLEMENTED ANY INTERNAL CORRECTIVE ACTIONS OR CHANGES TO ITS PERFUSION OR TRANSPORTATION PROCESSES. WE WILL CERTAINLY ENTERTAIN FUTURE CORRECTIVE AND/OR PREVENTATIVE MEASURES DEPENDING ON THE MANUFACTURER'S FINDINGS AND GUIDANCE. DUE TO THESE EVENTS THE INTENDED RECIPIENT WAS NOT ABLE TO RECEIVE THE KIDNEY FOR TRANSPLANT. THE ACCEPTING SURGEON DECLINED THE KIDNEY STATING THAT THE RISK WAS TOO HIGH. WE WERE ABLE TO SUCCESSFULLY REALLOCATE THE KIDNEY TO ANOTHER TRANSPLANT CENTER FOR TRANSPLANT TO ANOTHER RECIPIENT. THERAPY DURATION: 6 HOURS.