Description of Event or Problem · 1
YOU ARE FREE TO ADD MY REPORT TO YOUR DATABASE, AND TO INCLUDE MY NAME, AND TO CONTACT ME FOR FURTHER INFORMATION, THANK YOU FOR YOUR RESPONSE AND INTEREST, AS YOU SEE FIT AND AS THIS ADVANCES YOUR OVERSIGHT EFFORTS. THIS EVENING WE WERE BACK AT CARDIO THORACIC INTENSIVE CARE UNIT -- CT ICU -- AND SAW THE PORTABLE XRAY MACHINE COME BY FOR ANOTHER ROUND OF PICTURES, WE ARE LOOKING FOR ABDOMINAL WATER, I UNDERSTAND, THE PATIENT IS EDEMATOUS. THE XRAY MACHINE IS LARGER THAN A SUPERMARKET CART, AND LOOKS VERY HEAVY, AND MANIPULATES DIRECTIONALLY WITH GREAT DIFFICULTY - GREAT INERTIA OF MOVEMENT OR MOMENTUM, OR WHATEVER THE PHRASE IS - WHEN IT STARTS GOING IN ONE DIRECTION IT WANTS TO KEEP GOING IN THAT DIRECTION, AND AN INADVERTENT MOVEMENT CANNOT BE EASILY CORRECTED. THE BOX IS BULKY ALSO AND IT IS IMPOSSIBLE TO SEE OVER AND AROUND AND IN FRONT OF THE MACHINE - SO THE AMAZEMENT IS THAT THIS ACCIDENT HAS NOT HAPPENED BEFORE (BUT PLEASE READ ON). THE ROOM IS DARKENED FOR PURPOSES OF THE XRAY SNAPSHOT, OBVIOUSLY RADIOGRAPHY IS NOT LIGHT SENSITIVE, BUT I GATHER OR INFER THAT THE XRAY MACHINE PROJECTS A SQUARE LIGHT IMAGE WHERE THE RADIOGRAPH IS FOCUSED, TO MAKE SURE THAT THE EXPOSURE IS WHAT IS WANTED, WITH A SHADOWED CROSS-HAIR FOCAL POINT. THIS IS A FAINT LIGHT, AND SO THIS IS WHY, BY INFERENCE, THE ROOM IS DARKENED. THE ROOM REMAINED DARKENED WHILE THE XRAY CART IS NOW MUSCLED OR TRUNDLED OUT OF THE ROOM. SUCH A VERY LARGE AND HEAVY AND BULKY MACHINE CAN EASILY ROLL OVER A ONE INCH OR 3/4 TUBE, OR PULL IT AGAINST THE RESISTANCE OF TAPE HOLDING THE AIR HOSE INTO THE CHEST WALL, WITHOUT ANY AWARENESS BEING TRANSMITTED UP THROUGH THE HEAVY MACHINERY AND WHEEL SYSTEM, THAT THERE WAS AN ENCOUNTER. SO NOW WE THINK WE KNOW WHAT HAPPENED. I WAS TRYING TO DECIPHER WHY THE XRAY BOX IS SO HEAVY BY APPEARANCES BY AND BY INERTIA OF MOVEMENT, AND THE WHEELS ARE VERY LARGE ALSO, AND THEN I REALIZED THAT WE NEED A LEAD CONTAINER TO CONTAIN THE RADIATION EXCEPT FOR THE PORTION THAT IS AIMED AND OPENED FOR RADIOGRAPHS. I AM NOT SURE HOW TO SOLVE THIS PROBLEM, VARIOUS OPERATOR ADVISORIES ARE ONLY THAT, AND AS WE LEARN IN PRODUCT LIABILITY, AS WE GET SMARTER FAILURE-PROOF SYSTEMS IDIOT-PROOF SYSTEMS, WE GET SMARTER IDIOTS. I WOULD THINK, FOR EXAMPLE, THAT MY KLAXON SYSTEM WOULD NOT WORK - THESE ROOMS ARE VERY LOUD ANYWAY, AND EVEN IF THE KLAXON WERE HEARD, THE INERTIA OF MOTION OF THE XRAY CART WOULD MAKE A SUDDEN REVERSE IMPOSSIBLE. SO MAYBE WE CAN HAVE A LITTLE CLOSED CIRCUIT TELEVISION ON THE CART, AIMING DOWN AT THE FLOOR IN FRONT OF THE CAR, SORT OF LIKE MANY CARS NOW HAVE A CAMERA POINTED OUT THE BACK OF THE CAR FOR WHEN YOU BACK UP... BUT WE HAVE HAD PORTABLE XRAY CARTS FOR A VERY LONG TIME, SO THERE SHOULD BE A PRETTY GOOD DATABASE ON THIS TYPE OF ACCIDENT, AND MY SUGGESTIONS ARE ABOUT XRAY CARTS, NOT ABOUT THORATEC. SO BACK TO THORATEC. THE PATIENT IS ALSO INTUBATED FOR RESPIRATION, THESE DEVICES HAVE LOTS OF HOSES, ONE GOES FROM THE RESPIRATION DEVICE TO THE PATIENT AND ONE GOES (RETURNS) BACK FROM THE PATIENT TO THE DEVICE, I LOOKED TO SEE WHY THE XRAY CART HAD NOT RUN OVER THE RESPIRATION HOSES. THE RESPIRATION HOSES ARE HELD ALOFT ABOVE THE PATIENT AND ABOVE THE FLOOR BY AN ARM WHAT IS PART OF (INTEGRAL TO) THE RESPIRATION MACHINE, IT IS A KIND OF JOINTED ARM, SURELY WITH LOCKS AND SWIVELS AND THE LIKE, THAT KEEPS THE RESPIRATION TUBES -- OFF THE FLOOR -- OFF THE FLOOR -- OFF THE FLOOR -- AND FROM A LAYMAN'S POINT OF VIEW, THIS *COULD* BE AN INTEGRAL PART OF THE THORATEC BOX, BUT THEN, EVERYTHING WE SEE AND EVERYTHING WE DO NOT SEE, IS A MILLION DIFFERENT DESIGN TRADE OFFS, SO THESE REDESIGNS ARE OF COURSE PROBLEMATIC, AND I AM AWARE THAT EASILY, IN BETA TESTING, THE ARM DID NOT EXIST AND SNAGGED WITH SOMETHING ELSE. WE ARE HAPPY TO BE A DATA POINT IN REAL WORLD BETA TESTING, BUT WE SHOULD LIKE TO BE A POSITIVE DATA POINT. ONE OTHER THING, AT LEAST, BOTHERED ME. THIS IS A BI VENTRICULAR ASSIST DEVICE, THE LEFT SIDE AND THE RIGHT SIDE, THE HEART HAVING TWO SIDES FOR PURPOSES OF THIS DISCUSSION. IT DOES SEEM VERY IMPORTANT TO NOT CONNECT THE RIGHT HOSE TO THE LEFT CHAMBER AND THE REVERSE THE SIDES, LEFT AND RIGHT, ARE DESIGNATED BY A MASKING-TAPE-STRIP -- ONE AT THE R-VAD PANEL ON THE FRONT OF THE MACHINE, AND ONE AT THE L-VAD, AND A HANDWRITTEN ENTRY. THIS IS PROBABLY SUFFICIENT, BUT SEEMS, RATHER, HI-TACK, AS WE USED TO SAY ('TACK' SHORT FOR TACKY), IN LIEU OF HIGH-TECH LEFT-VS-RIGHT DESIGNATION, AGAIN SOME IDIOT-PROOFING WOULD SEEM USEFUL, LIKE MISMATCHED THREADING, FOR EXAMPLE, OXYGEN THREADS ARE REVERSE DIRECTION FROM ANESTHESIA THREADS, TO AVOID CROSS-HOSING IN OR CIRCUMSTANCES ANYWAY, THIS IS MY SUMMARY OF OBSERVATIONS, REFLECTIONS, AND SUGGESTIONS. REGARDING THORATEC VENTRICULAR ASSIST DEVICES (THE ONE WITH TWO RECENT PRODUCT ADVISORIES INCLUDING A CLASS ONE ADVISORY). WE ARE THE FAMILY OF A HEART FAILURE PATIENT WHO RECENTLY HAD A BI VENTRICULAR ASSIST DEVICE IMPLANTED. THIS IS OPEN HEART SURGERY AND THE PATENT WAS THEN TRANSPORTED TO CARDIO THORACIC INTENSIVE CARE UNIT FOR POST-OP. IN POST-OP, THERE WAS A ROUTINE X-RAY EXAMINATION, PORTABLE XRAY MACHINE, INTO THE ROOM, BEDSIDE. THE MED-TECH MANAGED TO RUN THE WHEELS OF THE XRAY MACHINE OVER THE AIR HOSES THAT KEEP THIS BOY ALIVE, THEN WHILE BACKING UP MANAGED TO PULL THE HOSES HALF OUT OF THE CHEST AND TO BREAK THE ELECTRICAL WIRE/SENSOR INSIDE THE AIR HOSE, SUCH THAT THERE WAS NO LONGER ANY ELECTRICAL FEEDBACK TO THE BASE UNIT AS TO WHAT WAS HAPPENING IN THE HEART. THIS INCIDENT REQUIRED A RETURN TO OR FOR SURGERY, TO SWAP OUT THE NOW-BROKEN RVAD (WE WERE LUCKY, IT WAS NOT THE LEFT VAD), WE WERE NOW TALKING ABOUT HE NUMBER OF MINUTES ONE CAN LIVE WITH A DISABLED RIGHT VENTRICLE. THE PATIENT IS ONE OF THE FIVE PERCENT OR SO, WHO HAS AN ALLERGIC REACTION TO THE ROUTINE ANTI COAGULANT ADMINISTERED AT THIS TIME, HEPARIN, THIS ALLERGIC REACTION IS CALLED HIT, OR HEPARIN INDUCED THROMBOSIS. SO IN OUR CASE EVEN MORE THAN USUAL, WE DON'T WANT TO PULL OUT THE HOSES, THIS WAS THE FLOOR (HOSPITAL) MODEL, NOT THE PORTABLE MODEL WHICH ALREADY HAS A PRODUCT ADVISORY ON PULLING OUT THE HOSES, IN OUR CASE THERE HAVE BEEN ABOUT SIX OR EIGHT TRANSFUSION UNITS, BECAUSE OF THE SECOND CYCLE OF VAD IMPLANTATION, AFTER THE FIRST CYCLE THERE WAS MAX ONE UNIT. SO MAYBE THERE HAS TO BE: SOME AFTERMARKET INQUIRY ON ROLLED-OVER AIR HOSES IN THE FLOOR MODEL -- WHEN I WAS DOING NDA'S FOR FDA APPROVAL, THE FDA ETC WERE VERY INTERESTED IN EVEN THE MOST RARE OF ADVERSE REACTIONS, BECAUSE THE SMALL SAMPLES INVOLVED IN NDA TRIALS MEANT THAT ANY INCIDENT COULD BE THE REPRESENTATIVE OF MANY SUCH INSTANCES. A PRODUCT USAGE ADVISORY - "DO NOT ROLL XRAY PORTABLE MACHINES OVER AIR HOSES AND THEN BACK OUT WHILE PULLING AIR HOSES OUT OF THE PATIENT' CHEST AND BREAKING THE SENSOR INSIDE THE AIR HOSE". AN INDUSTRY REPORT - HAVE THERE BEEN ANY OTHER SUCH INSTANCES OF HOSES BEING DAMAGED, IN ICU, ETC, THE FLOOR MODEL. IN RESPONSE TO THIS, THE ICU LIFTED THE HOSES OFF THE FLOOR AND PUT THEM ON THE BED! - THIS COULD BE ADDED TO A MANDATORY ADVISORY ON THE USAGE NOTES OF THIS PRODUCT. THE ICU ALSO TAPED THE ELECTRICAL CONNECTION TO THE WALL ONTO THE WALL, JUST IN CASE THE XRAY CART TRIED TO PULL OUT THE ELECTRICAL CORD ALSO - DOESN'T SAY MUCH FOR THE BATTERY BACKUP -- THE TAPE WOULD FIGHT BACK, I SUPPOSE. THERE DOES NEED TO A FAIL-SAFE SYSTEM, FOR EXAMPLE, THERE HAS TO BE DESIGNED A WEAK POINT SO THAT HOSES WILL FAIL WHERE YOU WANT THEM TO FAIL, NOT WHERE THOSE HOSE DECIDES TO FAIL, WE ARE NOT AWARE OF SUCH, PERHAPS SOME KLAXON TO STOP THE HOSE ROLLOVER, SORT OF LIKE A CAR ALARM THAT GOES OFF WHEN SOMEONE LEANS ON YOUR CAR.