SENSICA UO MONITOR ICU

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICES WOULD CRASH AND REBOOT WHEN ATTEMPTING TO START A PATIENT MONITORING SESSION OR WOULD CONTINUALLY CRASH OR REBOOT BEFORE LOADING TO THE TERMS AND AGREEMENTS SCREEN. THIS WOULD ONLY OCCUR SHORTLY AFTER CONNECTING THE RING AND ALSO WHEN LEAVING THE RING CONNECTED. PER ADDITIONAL INFORMATION RECEIVED ON 13-JUN-2022, IT WAS STATED THAT WHEN TROUBLESHOOTING, THIS DEVICE WOULD POWER ON AND LOAD TO THE SPLASH SCREEN AND THE INITIAL SCREEN WHERE A USER CREATED A NEW PATIENT SESSION WITHOUT ISSUE. THEY LEFT THE DEVICE ALONE FOR A FEW MINUTES TO SEE IF IT WOULD CRASH OR REBOOT, BUT NOTHING HAD HAPPENED. THEN THEY ATTEMPTED TO CREATE A NEW PATIENT SESSION, AND ABOUT 15 SECONDS AFTER ADDING THE RING THEY DID NOT EVEN ATTEMPT TO ADD THE TUBE OR BAG, THE DEVICE WAS CRASHED AND REBOOTED. THEY REPEATED THIS A FEW TIMES WITH THE SAME RESULTS EACH TIME. THEY ALSO NOTICED, IF LEFT THE RING ON WHILE THE SENSICA REBOOTED, THE DEVICE WOULD CONTINUOUSLY REBOOT AND DID WATCHED IT REBOOT AT LEAST 4 TIMES IN A ROW. THE DEVICE WOULD CRASH AND REBOOT AGAIN EVERY TIME RIGHT BEFORE THE USER LICENSE TERMS OR AGREEMENTS BOX APPEARED. ANOTHER OBSERVATION WAS THAT THE ERROR TELLING USERS TO REMOVE THE RING WHILE THE SENSICA BOOTED UP NEVER ONCE APPEARED AND IT SHOULD HAVE APPEARED. IF THEY REMOVED THE RING AT ANY POINT, THE DEVICE WOULD BOOT NORMALLY TO THE SPLASH SCREEN AGAIN. NEXT, FROM THE SPLASH SCREEN, THEY RUN THE SENSICA UTILITY APP ON THE DEVICE. THE UTILITY APP RAN WITHOUT ISSUE UNTIL THEY ADDED THE RING. AFTER CONNECTING THE RING AND CLICKING READ ON THE MEASUREMENTS TAB, THE DEVICE IMMEDIATELY CRASHED AND REBOOTED BY ITSELF AGAIN IN THE SAME MANNER DESCRIBED ABOVE. IT SEEMED THERE WAS SOME ISSUE BETWEEN THE HARDWARE AND SOFTWARE ON THE RING BECAUSE THE PROBLEM SO FAR ONLY OCCURRED RIGHT AFTER THE RING WAS CONNECTED. AN EXAMPLE THAT WOULD CAUSE THE DEVICE TO CRASH OR REBOOT IF IT FAILED WOULD BE IF THE I2C SIGNAL TO THE RING'S ELECTRICALLY ERASABLE PROGRAMMABLE READ-ONLY MEMORY (EPROM) WAS DISCONNECTED, OR THE SOFTWARE FAILED TO RECOGNIZE THE CONNECTION. IN THIS CASE, THE WATCHDOG SHOULD CRASH AND REBOOT THE DEVICE. THEY DID NOT SEE ANY VISIBLE DAMAGE TO THE GOLD PINS AND DID NOT CAPTURE THE GOLD PINS IN VIDEOS OF THIS ISSUE. THIS DEVICE WAS PLACED ASIDE AND WOULD NEED TO BE SHIPPED OUT FOR SERVICE AND REPAIR.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICES WOULD CRASH AND REBOOT WHEN ATTEMPTING TO START A PATIENT MONITORING SESSION OR WOULD CONTINUALLY CRASH OR REBOOT BEFORE LOADING TO THE TERMS AND AGREEMENTS SCREEN. THIS WOULD ONLY OCCUR SHORTLY AFTER CONNECTING THE RING AND ALSO WHEN LEAVING THE RING CONNECTED. PER ADDITIONAL INFORMATION RECEIVED ON 13-JUN-2022, IT WAS STATED THAT WHEN TROUBLESHOOTING, THIS DEVICE WOULD POWER ON AND LOAD TO THE SPLASH SCREEN AND THE INITIAL SCREEN WHERE A USER CREATED A NEW PATIENT SESSION WITHOUT ISSUE. THEY LEFT THE DEVICE ALONE FOR A FEW MINUTES TO SEE IF IT WOULD CRASH OR REBOOT, BUT NOTHING HAD HAPPENED. THEN THEY ATTEMPTED TO CREATE A NEW PATIENT SESSION, AND ABOUT 15 SECONDS AFTER ADDING THE RING THEY DID NOT EVEN ATTEMPT TO ADD THE TUBE OR BAG, THE DEVICE WAS CRASHED AND REBOOTED. THEY REPEATED THIS A FEW TIMES WITH THE SAME RESULTS EACH TIME. THEY ALSO NOTICED, IF LEFT THE RING ON WHILE THE SENSICA REBOOTED, THE DEVICE WOULD CONTINUOUSLY REBOOT AND DID WATCHED IT REBOOT AT LEAST 4 TIMES IN A ROW. THE DEVICE WOULD CRASH AND REBOOT AGAIN EVERY TIME RIGHT BEFORE THE USER LICENSE TERMS OR AGREEMENTS BOX APPEARED. ANOTHER OBSERVATION WAS THAT THE ERROR TELLING USERS TO REMOVE THE RING WHILE THE SENSICA BOOTED UP NEVER ONCE APPEARED AND IT SHOULD HAVE APPEARED. IF THEY REMOVED THE RING AT ANY POINT, THE DEVICE WOULD BOOT NORMALLY TO THE SPLASH SCREEN AGAIN. NEXT, FROM THE SPLASH SCREEN, THEY RUN THE SENSICA UTILITY APP ON THE DEVICE. THE UTILITY APP RAN WITHOUT ISSUE UNTIL THEY ADDED THE RING. AFTER CONNECTING THE RING AND CLICKING READ ON THE MEASUREMENTS TAB, THE DEVICE IMMEDIATELY CRASHED AND REBOOTED BY ITSELF AGAIN IN THE SAME MANNER DESCRIBED ABOVE. IT SEEMED THERE WAS SOME ISSUE BETWEEN THE HARDWARE AND SOFTWARE ON THE RING BECAUSE THE PROBLEM SO FAR ONLY OCCURRED RIGHT AFTER THE RING WAS CONNECTED. AN EXAMPLE THAT WOULD CAUSE THE DEVICE TO CRASH OR REBOOT IF IT FAILED WOULD BE IF THE I2C SIGNAL TO THE RING'S ELECTRICALLY ERASABLE PROGRAMMABLE READ-ONLY MEMORY (EPROM) WAS DISCONNECTED, OR THE SOFTWARE FAILED TO RECOGNIZE THE CONNECTION. IN THIS CASE, THE WATCHDOG SHOULD CRASH AND REBOOT THE DEVICE. THEY DID NOT SEE ANY VISIBLE DAMAGE TO THE GOLD PINS AND DID NOT CAPTURE THE GOLD PINS IN VIDEOS OF THIS ISSUE. THIS DEVICE WAS PLACED ASIDE AND WOULD NEED TO BE SHIPPED OUT FOR SERVICE AND REPAIR.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE COULD BE INCORRECT IMPLEMENTATION OF ALARMS BY SYSTEM SOFTWARE. HOWEVER, THIS CANNOT BE CONFIRMED. IF THEY REMOVED THE RING AT ANY POINT, THE DEVICE WOULD BOOT NORMALLY TO THE SPLASH SCREEN AGAIN. THIS DEVICE WAS PLACED ASIDE AND WOULD NEED TO BE SHIPPED OUT FOR SERVICE AND REPAIR. ALL GOOD FAITH ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THE OUTCOME OF THE REPAIR CANNOT BE DETERMINED AT THIS TIME. IN THE EVENT THAT INFORMATION REGARDING THE OUTCOME OF THE REPAIR AND THE STATUS OF THE DEVICE IS RECEIVED, THIS RECORD WILL BE REOPENED TO UPDATE THE INVESTIGATION. IT IS UNKNOWN IF THE DEVICE MET SPECIFICATIONS AND WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS IN USE ON A PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "1.1 INTRODUCTION THIS MANUAL PROVIDES THE INDICATIONS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE WITH THE BD SENSICA¿ URINE OUTPUT SYSTEM. CAREFULLY READ THIS MANUAL IN ITS ENTIRETY BEFORE USING THE BD SENSICA¿ URINE OUTPUT SYSTEM. FAILURE TO FOLLOW THESE INSTRUCTIONS MAY RESULT IN IMPROPER USE OF THIS DEVICE. 1.2 INDICATIONS FOR USE INDICATIONS: THE BD SENSICA¿ URINE OUTPUT SYSTEM IS AN AUTOMATED SYSTEM FOR CONTINUOUS MONITORING OF URINE OUTPUT (UO) AND CORE BLADDER TEMPERATURE WHEN CONNECTED TO A TEMPERATURE-SENSING FOLEY CATHETER. TARGET POPULATION: THE BD SENSICA¿ URINE OUTPUT SYSTEM IS INTENDED FOR BEDSIDE MONITORING OF URINE OUTPUT FOR ANY PATIENT WITH AN INDWELLING, UROLOGICAL CATHETER, DRAINAGE TUBING AND COLLECTION BAG, TYPICALLY IN CRITICAL CARE SETTINGS OR WHERE CLOSE MONITORING OF URINE OUTPUT IS DESIRED. THE BD SENSICA¿ URINE OUTPUT SYSTEM IS ALSO INTENDED FOR MONITORING CORE BLADDER TEMPERATURE WHEN USED WITH THE BD SENSICA¿ TEMPERATURE MONITOR MODULE AND A BD 400 SERIES TEMPERATURE-SENSING FOLEY CATHETER OR EQUIVALENT. 1.3 CONTRAINDICATIONS THERE ARE NO KNOWN CONTRAINDICATIONS FOR USE WITH PATIENTS WHO HAVE INDWELLING, UROLOGICAL CATHETERS IN PLACE. 1.4 WARNINGS (EMC) AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THE CHARTS AT THE END OF THESE INSTRUCTIONS FOR USE (APPENDIX A). PORTABLE AND MOBILE RADIOFREQUENCY (RF) COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. THE BD SENSICA¿ URINE OUTPUT SYSTEM SHOULD NOT BE STACKED WITH OTHER EQUIPMENT. THE BD SENSICA¿ URINE OUTPUT SYSTEM HAS A DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK OF APPLIED PARTS CLASSIFIED AS TYPE BF. THIS DEVICE IS CLASSIFIED AS AN IEC CLASS I DEVICE. WHEN USING CLASS 1 XP POWER MODEL NUMBER: ALM65US12 POWER SUPPLY, TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH. DO NOT IMMERSE OR SUBMERGE THE BD SENSICA¿ URINE OUTPUT STAND, DISPLAY MONITOR, RING, TEMPERATURE MONITOR MODULE, TEMPERATURE SENSOR CABLES, OR MONOPLUG ADAPTER IN WATER OR OTHER LIQUIDS. DO NOT POUR LIQUIDS OVER THE DISPLAY MONITOR, RING, TEMPERATURE MONITOR, CABLES OR MONOPLUG ADAPTER. IF LIQUIDS ACCIDENTALLY SPILL ONTO THE DEVICE(S), WIPE OFF LIQUID WITH SOFT CLOTH AS SOON AS POSSIBLE. SEE SECTION 14 FOR COMPLETE CARE INSTRUCTIONS. THIS DEVICE IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE MIXTURES. THIS DEVICE IS NOT SUITABLE FOR USE IN OXYGEN RICH ENVIRONMENTS. WARNING: THIS PRODUCT CAN EXPOSE YOU TO DI(2-ETHYLHEXYL) PHTHALATE (DEHP), WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM. OPERATION WARNINGS FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED PHYSICIAN. THE BD SENSICA¿ URINE OUTPUT SYSTEM SHOULD ONLY BE USED ON THE REQUEST BY AND UNDER THE DIRECTION OF A LICENSED PHYSICIAN. DO NOT USE BD SENSICA¿ RING (DISPOSABLE) IF PRODUCT APPEARS BROKEN. THE ¿ACCURACY CHECK¿ SHOULD BE PERFORMED PRIOR TO FIRST USE, WHEN THERE IS A QUESTION ABOUT SYSTEM ACCURACY, AND/OR AFTER ANY SERVICING OR REPAIRS TO ENSURE ACCURATE MEASUREMENTS. ALWAYS USE A NEW BD SENSICA¿ RING TO COMPLETE AN ACCURACY CHECK. IF THE ACCURACY CHECK FAILS CALL BD CUSTOMER SERVICE. THIS SELF-TEST TAKES ABOUT ONE MINUTE AND CAN BE ACCESSED FROM THE NEW PATIENT AND SETTINGS SCREEN OR FROM THE ADMINISTRATOR SETTINGS. DO NOT CHANGE TIME AND DATE SETTINGS DURING SYSTEM OPERATION. TIME AND DATE SETTINGS SHOULD BE SET WHEN SYSTEM IS INITIALLY INSTALLED OR BETWEEN MONITORING SESSIONS, IF NEEDED. ENSURE THAT THE URINE DRAINAGE BAG HANGING ON THE BD SENSICA¿ RING IS ALWAYS BELOW THE LEVEL OF THE PATIENT¿S BLADDER TO MAINTAIN CONTINUOUS, GRAVITY FLOW OF URINE INTO THE COLLECTION BAG. WHEN CONNECTING THE SINGLE PATIENT USE BD SENSICA¿ RING TO THE SYSTEM STAND, USE A FIRM, CLOCKWISE TWISTING MOTION. IN ORDER TO AVOID DAMAGING COMPONENTS, DO NOT APPLY EXCESSIVE FORCE OR TORQUE TO THE RING OR THE SYSTEM¿S RING INTERFACE WHEN CONNECTING THE DEVICE. TO PROPERLY STABILIZE THE SYSTEM FOR ACCURATE URINE OUTPUT MEASUREMENT, ALWAYS USE THE BD SENSICA¿ TUBE BAND POSITIONING STRIP PROVIDED IN THE BD SENSICA¿ RING KIT TO CORRECTLY POSITION THE TUBE BAND ON THE DRAINAGE TUBING. INSERT THE DRAINAGE TUBING IN THE TUBE HOLDER WITH THE TUBE BAND IN THE TUBE HOLDER WINDOW. THE BAND SHOULD BE PERMANENTLY ATTACHED TO THE DRAINAGE TUBING USING THE PROVIDED PEEL-OFF ADHESIVE BACKING. WHEN REMOVING THE BAG FROM THE RING FOR ANY REASON, SIMPLY PULL THE TUBING OUT OF THE TUBE HOLDER. WHEN RE-HANGING THE BAG, REINSERT THE TUBING INTO THE TUBE HOLDER WITH THE TUBE BAND IN THE TUBE HOLDER WINDOW. DO NOT TWIST OR KINK TUBING AT ANY TIME DURING USE. THE TUBE BAND POSITIONING STRIP DOES NOT NEED TO BE APPLIED WHEN USING A DRAINAGE BAG THAT COMES WITH PRE-MARKED TUBING. SYSTEM COMPONENTS. ADDITIONALLY, THE DEVICE STAND SHOULD BE KEPT LEVEL DURING A MONITORING SESSION AS TILTING OF THE DEVICE MAY IMPACT THE ACCURACY OF URINE OUTPUT MEASUREMENTS. USE THE CROSSBAR HANDLE ON THE BACK OF THE DEVICE TO MOVE THE BD SENSICA¿ URINE OUTPUT SYSTEM. DO NOT PICK UP THE DEVICE FROM THE FRONT OF THE SYSTEM. USE CAUTION NOT TO DROP THE SYSTEM WHILE MOVING THE SYSTEM. TAKE CARE NOT TO TRIP OVER THE BD SENSICA¿ URINE OUTPUT SYSTEM OR THE POWER CORD TO AVOID USER INJURY OR ACCIDENTALLY PULLING OUT THE INDWELLING CATHETER. DO NOT SET ALARM LIMITS TO EXTREME VALUES THAT CAN RENDER THE ALARMS USELESS. USE ONLY THE BD SENSICA¿ RING WHEN USING THE BD SENSICA¿ URINE OUTPUT SYSTEM FOR CORRECT OPERATION. DO NOT LEAN ON, PULL ON, OR ALLOW ANYTHING TO REST ON THE URINE COLLECTION BAG, BD SENSICA¿ RING OR DRAINAGE TUBING WHILE THE URINE BAG IS HANGING ON THE BD SENSICA¿ URINE OUTPUT SYSTEM. THIS WILL GENERATE A SYSTEM ALARM, COULD CAUSE ERRONEOUS URINE OUTPUT READINGS, AND MAY BREAK THE LOAD CELL MEASUREMENT ASSEMBLY. BREAKAGE DUE TO EXCESSIVE FORCE/WEIGHT APPLIED TO THE RING OR LOAD CELL ASSEMBLY WILL CONSTITUTE MISUSE OF THE SYSTEM AND REPAIRS WILL NOT BE COVERED UNDER WARRANTY. DO NOT STERILIZE ANY COMPONENT OF THE BD SENSICA¿ URINE OUTPUT SYSTEM. TO CLEAN THE DISPLAY TOUCH SCREEN, WIPE WITH A SOFT CLOTH OR USE A GERMICIDE WIPE SUCH AS SUPER SANI-CLOTH®. DO NOT SPRAY HARSH CLEANERS DIRECTLY ON THE DISPLAY TOUCH SCREEN. SEE SECTION 14 FOR COMPLETE CARE AND MAINTENANCE OF THE BD SENSICA¿ URINE OUTPUT SYSTEM. THE BD SENSICA¿ RING IS A SINGLE PATIENT USE DEVICE. AFTER ENDING PATIENT MONITORING, DISINFECT RING USING FACILITY GERMICIDE WIPES. AFTER USE, THE RING MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE, FACILITY PROCEDURES, AND APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. DO NOT ATTEMPT TO REPLACE THE SYSTEM¿S BATTERY. CONTACT BD CUSTOMER SERVICE AT +1.844.823.5433 TO ARRANGE FOR PRODUCT SERVICE. CONTACT BD CUSTOMER SERVICE REGARDING SERVICEABLE COMPONENTS IN THE BD SENSICA¿ URINE OUTPUT SYSTEM. DO NOT ATTEMPT TO OPEN CONTROL COVERS OR REPAIR THE BD SENSICA¿ URINE OUTPUT SYSTEM WITHOUT PROPER TRAINING AND APPROVED REPLACEMENT KITS. TO DO SO, MAY ALTER URINE OUTPUT MEASUREMENTS AND VOID THE WARRANTY. CONTACT CUSTOMER SERVICE TO REPORT SYSTEM PROBLEMS AND ARRANGE FOR PRODUCT SERVICE. NOTE: THERE ARE NO SERVICEABLE PARTS IN THE TEMPERATURE MONITOR MODULE. DO NOT ATTEMPT TO OPEN THE BD SENSICA¿ TEMPERATURE MONITOR MODULE HOUSING. WITH THE BD SENSICA¿ TEMPERATURE MONITOR MODULE, BD SENSICA¿ TEMPERATURE SENSOR CABLE AND MONOPLUG ADAPTER, ONLY USE A BD 400 SERIES TEMPERATURE-SENSING FOLEY CATHETER OR EQUIVALENT. DO NOT ATTEMPT TO USE THE BD SENSICA¿ URINE OUTPUT SYSTEM WITH ANY CRITICORE¿ DISPOSABLE PRODUCTS. AFTER USE, THE BD SENSICA¿ URINE OUTPUT SYSTEM, TEMPERATURE MONITOR MODULE, TEMPERATURE SENSOR CABLE, AND MONOPLUG ADAPTER MAY BE A POTENTIAL BIOHAZARD. CLEAN AND DISINFECT THE PRODUCTS BEFORE DISPOSAL. HANDLE AND DISPOSE OF THE PRODUCTS IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE, FACILITY PROCEDURES, AND APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. THESE PRODUCTS CONTAIN ELECTRICAL AND/OR ELECTRICAL EQUIPMENT, AND THE BD SENSICA¿ URINE OUTPUT SYSTEM (SCCS1002 AND SCCS1002E) CONTAINS A LITHIUM-ION BATTERY THAT MUST BE DISPOSED OF PER LOCAL LAWS AND REGULATIONS. DO NOT SIMULTANEOUSLY TOUCH THE PATIENT AND THE VISIBLE METAL CONTACTS OF THE TEMPERATURE MONITOR MODULE OR THE RING INTERFACE. PRECAUTIONS DURING SYSTEM START UP AND IN GENERAL PRACTICE, PLUG THE BD SENSICA¿ URINE OUTPUT SYSTEM INTO A WALL POWER SUPPLY WHENEVER POSSIBLE. THE SYSTEM SCREEN WILL DIM WHEN THE SYSTEM IS UNPLUGGED TO MAXIMIZE BATTERY LIFE. AFTER USING THE SYSTEM ON BATTERY BACK-UP, PLUG IT BACK INTO THE WALL POWER SUPPLY FOR RECHARGING AND TO AVOID SYSTEM SHUT DOWN DUE TO A DRAINED BATTERY. AFTER REMOVING A PATIENT FROM URINE OUTPUT MONITORING WITH THE BD SENSICA¿ URINE OUTPUT SYSTEM, SHUT DOWN THE SYSTEM COMPLETELY TO AVOID BATTERY DRAINAGE WHILE NOT IN USE. LOW PRIORITY ALARMS MAY INTERRUPT URINE OUTPUT MONITORING AND REQUIRE USER ACTION TO RESUME NORMAL URINE OUTPUT MONITORING FUNCTIONS. 1.6 LABELING SYMBOLS TABLE 1 BELOW PROVIDES A DESCRIPTION OF THE SYMBOLS USED ON THE BD SENSICA¿ URINE OUTPUT SYSTEM LABELING AND DOCUMENTATION."