Description of Event or Problem · 1
(B)(6) 2012. THIS VOLUNTARY REPORT RELATES TO THE FUNCTIONING OF THE PNEUMATIC BLOOD PRESSURE DEVICE OF THE DRAGER INFINITY DELTAXL + C700 + I.E. PART NUMBER (B)(4). WE HAVE RECENTLY PURCHASED (B)(6) OF THESE UNITS AND ARE EXPERIENCING THE FOLLOWING ISSUES WITH THE BLOOD PRESSURE COMPONENT OF THE DEVICE. WE HAVE DEPLOYED THESE DEVICES WITHIN OUR OPERATING ROOM SUITE FOR USE ON PATIENTS UNDERGOING ANESTHETIC SERVICES. THESE OCCURRENCES APPEAR ASSOCIATED WITH ALL OF THE DEVICES AND OCCUR ON A RELATIVELY CONSTANT BUT INTERMITTENT AND VARIABLE BASIS. IT IS OUR UNDERSTANDING THAT THIS PROBLEM IS NOT ISOLATED TO THE CONEMAUGH HEALTH SYSTEM BUT OTHER HOSPITALS USING THE INFINITY DELTAXL MONITOR. THE DELTAXL PNEUMATIC BLOOD PRESSURE CUFF APPEARS TO BE MORE SENSITIVE TO MOVEMENT THAN THE PREVIOUS DEVICES THAT WE EMPLOYED IN OUR PRACTICE. THE DELTAXL WILL "CYCLE" OVER AN INORDINATELY LONG PERIOD (UP TO FIVE MINUTES) TRYING TO DEVELOP A BLOOD PRESSURE. THE DELTAXL WHEN UNABLE TO DEVELOP A BLOOD PRESSURE FOR THE CLINICIAN, DOES THE FOLLOWING UNACCEPTABLE THINGS. SIMPLY STOPS WORKING. TRIES TO RE-CYCLE AGAIN. REPORTS AN ERROR "UNABLE TO READ BLOOD PRESSURE." THIS ERROR MESSAGE HAS BEEN INTERPRETED AS AN ISSUE WITH THE PATIENT UNDER ANESTHESIA NOT AN ERROR WITH THE MECHANICS OF THE MONITOR. CRNA'S AND ANESTHESIOLOGISTS HAVE BEEN TEMPTED TO BEGIN TREATMENT OF THE PATIENT BASED ON THIS MESSAGE. THESE ISSUES RESULT IN UNACCEPTABLE PERIODS OF ANESTHETIC ADMINISTRATION WITHOUT KNOWLEDGE OF THE PATIENT'S BLOOD PRESSURE TO SAFELY ADMINISTER ANESTHESIA. THERE IS NO DISCERNABLE PATTERN RELATED TO THIS FAILURE IN EITHER ROOM, BLOOD PRESSURE RANGE, PATIENT AGE OR SIZE. THE DELTAXL ISSUE MAY DEVELOP IF DURING THE USE OF THE DEVICE THE 90 DEGREE CONNECTION BECOMES ENSNARED UNDERNEATH THE FUNCTIONAL BLADDER COMPONENT OF THE CUFF. DRAGER MEDICAL HAS DONE SOME FIELD INVESTIGATION ON THIS ISSUE AND IN FACT WAS PRESENT IN OUR OPERATING ROOMS DURING ONE OF THESE FAILURES WHEN THE CRNA WAS FORCED TO USE MANUAL BLOOD PRESSURE CUFFS TO SAFELY ADMINISTER AN ANESTHETIC TO A PATIENT. HERE IS A BRIEF SUMMARY OF WHERE THEIR ISSUE IS AS OF THE DATE OF THIS REPORTING. THERE IS AN ISSUE AS DESCRIBED ABOVE WITH THE DELTAXL THAT CAN BE DEMONSTRATED BOTH CLINICALLY AND WITH STATIC BENCH TESTING OF THE DELTAXL BLOOD PRESSURE DEVICE. DRAGER FEELS THAT THERE ARE NO ISSUES WITH THE TRAINING OF THE CLINICIANS OR THE SOFTWARE SET-UP OR FUNCTION OF THE DEVICE. DRAGER TECHNICAL SUPPORT EXAMINED THE DEVICE IN QUESTION AND STATED THAT THE DEVICE IS FUNCTIONING PROPERLY AND PROPERLY PROGRAMMED. THERE IS AN ISSUE WITH THE DRAGER BLOOD PRESSURE CUFF. THIS CUFF IS ATTACHED TO THE MONITOR VIA A RUBBER HOSE THAT DOCKS WITH THE BLOOD PRESSURE CUFF AT A 90-DEGREE RIGHT ANGLE. DURING STATIC BENCH TESTING OF THE DEVICE, THE PROBLEM DESCRIBED ABOVE WAS ELICITED BY SLIGHT MANIPULATION OF THIS CONNECTION. OVER THE PAST TWO WEEKS, CONEMAUGH HOSPITAL, AFTER ASSURING ACCURACY THROUGH A STATIC BENCH TEST, USED DIFFERENT BLOOD PRESSURE CUFFS THAT DO NOT USE THIS 90-DEGREE TYPE OF CONNECTION AND WERE ABLE TO ALMOST ELIMINATE THE ISSUE.