Description of Event or Problem · 1
WE CURRENTLY USE THE RESPIRONICS V60 VENTILATOR FOR TRANSPORTING PATIENTS WITH HYPOXIC RESPIRATORY FAILURE WHO ARE BEING TREATED WITH NON INVASIVE VENTILATION. THE V-60 HAS A SPECIFIC TRANSPORT CAPACITY. WE EXPERIENCED A SIGNIFICANT SAFETY EVENT ASSOCIATED WITH THE V-60 AND AN AMVEX OXYGEN REGULATOR ON THE TRANSPORT OF A CRITICALLY ILL PATIENT. THE PATIENT REQUIRED 100% FIO2 VIA THE V-60. WHEN WE ATTEMPTED TO TRANSPORT THE PATIENT BY PLUGGING THE HIGH PRESSURE HOSE FROM THE V-60 INTO A SINGLE E-CYLINDER EQUIPPED WITH AN AMVEX CGA 870 REGULATOR WITH 50 PSI QUICK CONNECT THE DELIVERED FIO2 IMMEDIATELY FELL TO 40%. WE SAFELY TRANSPORTED THE PATIENT USING OTHER MEANS WITHOUT ANY PATIENT HARM. WE THEN LAB TESTED THE V-60 BY ATTACHING IT TO THE (B)(6) TEST LUNG VIA ET CONNECTOR WITH A SET RATE OF 14, VT 550, AND FIO2 OF 100%. THE ONLY LEAK IN THE SYSTEM WAS THROUGH THE WHISPER VALVE IN THE CIRCUIT WHICH IS STANDARD FOR THE MACHINE. WHEN PLUGGED INTO WALL GAS AT 50 PSI, DELIVERED FIO2 MEASURED WITH AN EXTERNAL, CALIBRATED MINI-OX ANALYZER WAS 100%. WHEN SWITCHED TO A SINGLE E CYLINDER WITH THE ABOVE REGULATOR, DFIO2 -DELIVERED FIO2- FELL TO 38%. WHEN RECONNECTED TO THE WALL, DFIO2 RETURNED TO 100%. WE THEN USED 2 E CYLINDERS EACH WITH A AMVEX CGA 870 REGULATOR WITH 50 PSI QUICK CONNECT, CONNECTED TO THE V-60 VIA THE OCTOPUS CONNECTOR SUPPLIED BY RESPIRONICS 3 HIGH PRESSURE CONNECTORS. USING 2 CYLINDERS, THE DFIO2 WAS MAINTAINED AT 100%. AT THIS POINT, WE ASSUMED THE V-60 REQUIRED 2 TANKS TO PROVIDE ADEQUATE FLOW IN ORDER TO MAINTAIN DFIO2 OF 100%. WE THEN DECIDED TO TRY A FLOWTEC GAUGE ON THE VENTILATOR WITH A SINGLE TANK. WHEN WE DID, THE DFIO2 REMAINED ON 100%, SAME SETTINGS, EVERYTHING THE SAME EXCEPT THE MAKE OF GAUGE WAS DIFFERENT. WE REPEATED THIS TESTING WITH 2 DIFFERENT V-60 VENTILATORS, WITH 4 FLOW TEC GAUGES AND 6 AMVEX GAUGES. WITH EACH ITERATION OF TESTING, THE AMVEX GAUGE WOULD CAUSE THE V-60 TO DROP ITS DFIO2 TO APX 40% WHEN SET ON 100%, WHILE THE FLOWTEC GAUGES WOULD WORK PERFECTLY FINE WITH THE V-60. WE THEN TESTED EACH GAUGE FOR PSI WHILE ATTACHED TO THE E CYLINDER. EACH GAUGE BOTH FLOWTEC AND AMVEX REGISTERED 60 PSI. IN ADDITION, WHEN THE AMVEX GAUGE WAS USED, THERE WAS AN AUDIBLE STRAINED SOUND COMING FROM THE AMVEX GAUGE, WHILE THE FLOWTEC GAUGE WAS ESSENTIALLY SILENT. THE CLINICAL ENGINEERING DEPARTMENT THEN REPEATED OUR TESTING, BUT ADDED FIO2 CHANGES INTO THE BENCH TESTING INCLUDING VARYING THE FIO2 FROM 21% TO 100%. THE V-60 VENTILATOR WAS ONLY ACCURATE UP TO 50% FIO2 WHEN CONNECTED TO A SINGLE AMVEX REGULATOR. THE FLOWTEC REGULATOR WAS ACCURATE AT ALL RANGES OF FIO2. CLINICAL ENGINEERING CONTACTED AMVEX AND SPOKE WITH THEIR ENGINEERING DEPARTMENT. THE AMVEX REGULATOR MAXIMUM OUTPUT IS 90 LITERS. THE V-60 VENTILATOR HAS A MAXIMUM FLOW OUTPUT OF 175 LITERS PER MINUTE. THIS IS A CLEAR PATIENT SAFETY RISK WHEN TRANSPORTING PATIENTS REQUIRING AN FIO2 GREATER THAN 50% WITH AN AMVEX CGA 870 REGULATOR. WE DO NOT BELIEVE THE V-60 PLATFORM IS THE CAUSE OF THE ISSUE, HOWEVER, USE OF THE V-60 DEVICE WITH A SINGLE AMVEX CGA 870 REGULATOR MAY PUT PATIENTS AT SIGNIFICANT RISK DUE TO THE INABILITY TO PROVIDE AN FIO2 GREATER THAN 50%. WE ARE AWARE OF RESPIRONICS PUBLICATION FIV-60 TRANSPORT GUIDELINES AND ITS RECOMMENDATION NOT TO USE THE GRAB AND GOFL TANKS. THE AMVEX REGULATOR SHOULD ALSO BE IDENTIFIED AS A POTENTIAL SAFETY HAZARD. WE ALSO RECOMMEND THAT RESPIRONICS SEND NOTICE TO ITS CUSTOMERS THAT TWO E CYLINDERS ARE REQUIRED FOR EVERY TRANSPORT. THIS IS NOT CLEAR IN YOUR PUBLICATION. IN ADDITION, THE V-60 TRANSPORT GUIDELINES STATE THAT ONLY 1 TANK SHOULD BE USED AT A TIME TO ASSURE THAT THE PATIENT WILL NOT RUN OUT OUR OXYGEN. BY MAKING THAT STATEMENT, USERS OF AMVEX GAUGES MAY NOT KNOW THAT IT REQUIRES 2 TANKS WITH AMVEX GAUGES CONNECTED AT THE SAME TIME IN ORDER TO PROVIDE ADEQUATE FLOW.