Description of Event or Problem · 0
WE HAVE A CATSMART CELL SAVER THAT HAS EXPERIENCED FOUR CATASTROPHIC FAILURES IN A SHORT PERIOD OF TIME (3/11, 4/22, 5/1, 7/19). THE LAST TIME IT FAILED WAS DURING A TRAUMA CASE WHILE IT CONTAINED ABOUT A THIRD OF THE PATIENT'S BLOOD VOLUME. THIS CAUSED AN UNSAFE CONDITION AND REQUIRED THE USE OF MORE BLOOD PRODUCTS DURING THE CASE WHILE (B)(6) IS A BLOOD SHORTAGE. HERE IS AN EXCERPT FROM A STAFF MEMBER INVOLVED IN THE JULY EVENT: ON FRIDAY JULY 19TH JUST BEFORE 4:30 PM A TRAUMA ALERT SOUNDED FOR A PATIENT WHO'D BEEN IN A CAR ACCIDENT SUFFERING GROSS INJURIES, LACERATIONS, INTERNAL BLEEDING, AND A BROKEN BACK. THIS PATIENT WAS NEARLY INSTANTLY TAKEN TO OUR SURGICAL UNIT FROM THE ED UNDER MASSIVE TRANSFUSION PROTOCOL. THE SURGEON AND ANESTHESIOLOGIST ORDERED CELL SAVER AND I DEPLOYED THIS CATSMART DEVICE. AS THE PATIENT WAS PROFOUNDLY BLEEDING, I STARTED WITH THE CLAMPED RESERVOIR AND BEGAN COLLECTING FROM SURGICAL SUCTION, WITH THE INTENT TO FINISH SETTING UP THE LOWER PORTIONS OF THE DEVICE AND BEGIN SALVAGE WITHOUT DELAYING THEIR SURGICAL SUCTION. WHEN I TURNED ON THE DEVICE AND TRIED TO LOAD IT, IT WOULD NOT LOAD THE TUBING INTO PUMPS (THE THREE CIRCULAR PADDED DEVICES ABOVE AND FURTHER AWAY FROM THE OPERATOR TO THE DISCUS-SHAPED CENTRIFUGE). I ATTEMPTED MANY TIMES TO WORK THE TOUCHSCREEN AND WHEN THAT FAILED, I ATTEMPTED TO SEE IF I COULD TRICK THE DEVICE BY CLOSING EVERYTHING ELSE, PUTTING THE TUBING IN CLOSE PROXIMITY TO THE SHOULD-BE-SPINNING DEVICES, AND PRIMING THE MACHINE. THE MACHINE WENT THROUGH OTHER STEPS OF THE PRIMING PROCESS BUT NEVER SPUN THE PUMPS OR CAPTURED THE TUBING. IT FROZE ON 0:00 AT THE END OF THE PRIMING COUNTDOWN AND MADE NO ERROR MESSAGE OR CHANGE IN SCREEN. HOPING THAT IT WOULD CORRECT ITSELF ON A RESET, I ATTEMPTED THE OLD POWER-DOWN-POWER-OFF TRICK. WHEN I POWERED IT DOWN HOWEVER, IT NEVER CAME BACK ON. I ATTEMPTED TO SWITCH POWER OUTLETS, GAVE IT A FEW MINUTES AND TRIED AGAIN, BUT IT NEVER POWERED BACK ON. BY THIS POINT I HAD ACCUMULATED MORE THAN TWO LITERS OF PATIENT BLOOD, REPRESENTING OVER A THIRD OF THE PATIENT'S TOTAL BLOOD IN MY COLLECTION BASIN. I RETRIEVED ANOTHER CATSMART MACHINE AND CALLED CLINICAL ENGINEERING, WHO WAS ABLE TO RUN TO THE ROOM AND HIT THE EMERGENCY RELEASE FOR THE DOOR OF THE MACHINE, ALLOWING ME TO TAKE THE ENTIRE SETUP INTO THE SECOND FUNCTIONING MACHINE (I COULD HAVE CLAMPED AND TAKEN ONLY THE RESERVOIR AND OPENED A NEW CENTRIFUGE AND INTERIOR SET). THE SECOND MACHINE WORKED WITHOUT ISSUE, AND BY THAT TIME I WAS APPROACHING THREE LITERS OF PATIENT SALVAGE. (THE PATIENT WAS RECEIVING OTHER ALLOGENIC BLOOD PRODUCTS OBVIOUSLY AT THIS TIME, FOR THREE LITERS IS OVER HALF TOTAL BLOOD VOLUME AND LETHAL WITHOUT REPLACEMENT.) THE REST OF THE CASE PASSED WITHOUT INCIDENT ON THE NEW MACHINE. I RETURNED OVER TWO LITERS OF SALVAGE TO THE PATIENT, WHO SURVIVED AND WILL RECOVER. BIOMED REMOVED THE MACHINE FROM SERVICE IMMEDIATELY AFTER THE CASE. FOLLOWING EACH OF THESE FAILURES, WE HAVE CONTACTED THE SUPPORT VENDOR (FRESENIUS KABI USA, LLC) FOR SERVICE RESTORATION. THEY HAVE REPLACED THE PCBA BOARD (MARCH, APRIL & JULY), THE DISPLAY CABLES (MAY), AND THE SOFTWARE CARD (MAY). AT THIS TIME WE DO NOT FEEL COMFORTABLE USING THIS EQUIPMENT GIVEN IT'S HISTORY OF FAILURES AND LACK OF ROOT CAUSE DETERMINATION FROM THE MANUFACTURER OR SUPPORT VENDOR. THE RESPONSE FROM THE SUPPORT VENDOR HAS BEEN DISMISSIVE AND EVASIVE, SO THE MACHINE HAS BEEN REMOVED FROM SERVICE UNTIL AN ACCEPTABLE PLAN OF ACTION HAS BEEN REALIZED. WHEN COMMUNICATING THIS ISSUE TO THE VENDOR, OUR CONCERNS HAVE BEEN DISMISSED. AN ACCIDENTAL CC REVEALED THAT FRESENIUS KABI WAS NOT BEING ENTIRELY TRUTHFUL WITH US REGARDING THEIR AVAILABILITY AND WAS WILLFULLY DELAYING RESPONSE TO OUR CONCERNS. WE HAVE ASKED THE VENDOR FOR A LOANER AND TO SEND THE PROBLEMATIC MACHINE BACK TO THE MANUFACTURER BUT REQUESTS HAVE BEEN DENIED. REFERENCE REPORTS MW5158372, MW5158373, MW5158374.