SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT WORKING AND THE ONLY WAY THE USER COULD GET IT TO WORK WAS BY REPLACING THE RING. THERE WAS NO PATIENT HOOKED UP TO THE DEVICE AND THE CHARGE NURSE INDICATED THAT THEY COULD NOT RESTART THE UNIT. REPRESENTATIVE TRIED TO RESTART THE UNIT AND VERIFIED THAT AFTER PUSHING THE POWER BUTTON, THE GRAPHIC USER INTERFACE SCREEN CAME UP ASKING IF THEY WERE SURE TO RESTART AND THE YES OPTION COULD NOT BE PRESSED. ADDITIONALLY, OTHER BUTTONS ON THE MAIN GRAPHIC USER INTERFACE WERE UNRESPONSIVE. FURTHER VISUAL INSPECTION OF THE SCREEN INDICATED THAT THERE WAS A PERSISTENT PHANTOM TOUCH THAT SHOWED UP AS A CIRCLE ON THE SCREEN. THE PERSISTENT PHANTOM TOUCH WAS DETERMINED TO BE THE CAUSE FOR WHY THE SCREEN WAS UNRESPONSIVE. A RESTART OF THE UNIT WAS TRIGGERED BY ATTACHING AND DETACHING THE RING MULTIPLE TIMES. REPRESENTATIVE STATED THAT UPON RESTART, THE PHANTOM TOUCH DISAPPEARED, AND THE SCREEN WAS FULLY FUNCTIONAL. PER ADDITIONAL INFORMATION RECEIVED ON 20-JUN-2022, THE SENSICA DEVICE WAS PULLED FROM THE FLOOR WITH A DO NOT USE STICKER, WITH NO ADDITIONAL DETAIL. THE UNIT WAS THEN GIVEN TO BD REPRESENTATIVE TO INVESTIGATE, THEY BROUGHT THE UNIT TO OUR CONFERENCE ROOM AND STARTED A MONITORING SESSION TO TRY IT OUT AND SEE IF IT WORKED. THEY ATTEMPTED TO ADD SOME WEIGHT TO SEE IF THE DEVICE WAS RECORDING CORRECTLY. AT FIRST, THEY TRIGGERED A SUDDEN INCREASE POSSIBLE ARTIFACT ALARM, AND REMOVED THE WEIGHT DURING STABILIZATION. THE DEVICE STABILIZATION ENDED AND DISPLAYED 0 ML. WHILE LOOKING OVER THE DEVICE, WE THEY TILTED IT AND TRIGGERED THE TILT ALARM A FEW TIMES. THEY ADDED SOME FLUID TO THE BAG, AND WAS ABLE TO INCREASE IT TO APPROXIMATELY 15 ML. THERE WAS A RANDOM JUMP UP TO ABOUT 69 ML THAT THEY CANNOT  COULD NOT ACCOUNT FOR. THE HOUR ENDED, AND THE DEVICE DISPLAYED ONLY THE NEW CURRENT HOUR. THEY ADDED ABOUT 10 ML WHICH IT READ AND CHECKED THE DATA SCREEN AND THE DATA FROM THE PREVIOUS HOUR WAS STILL PRESENT. WHEN RETURNING TO THE MAIN SCREEN IT STILL DID NOT SHOW THE FIRST PARTIAL HOUR. ONCE THE HOUR WAS UP, THE DEVICE CREATED A NEW HOUR AND STARTED DISPLAYING THE FIRST PARTIAL HOUR AS WELL (NEW HOUR WITH OLD MISSING HOUR).

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT WORKING AND THE ONLY WAY THE USER COULD GET IT TO WORK WAS BY REPLACING THE RING. THERE WAS NO PATIENT HOOKED UP TO THE DEVICE AND THE CHARGE NURSE INDICATED THAT THEY COULD NOT RESTART THE UNIT. REPRESENTATIVE TRIED TO RESTART THE UNIT AND VERIFIED THAT AFTER PUSHING THE POWER BUTTON, THE GRAPHIC USER INTERFACE SCREEN CAME UP ASKING IF THEY WERE SURE TO RESTART AND THE YES OPTION COULD NOT BE PRESSED. ADDITIONALLY, OTHER BUTTONS ON THE MAIN GRAPHIC USER INTERFACE WERE UNRESPONSIVE. FURTHER VISUAL INSPECTION OF THE SCREEN INDICATED THAT THERE WAS A PERSISTENT PHANTOM TOUCH THAT SHOWED UP AS A CIRCLE ON THE SCREEN. THE PERSISTENT PHANTOM TOUCH WAS DETERMINED TO BE THE CAUSE FOR WHY THE SCREEN WAS UNRESPONSIVE. A RESTART OF THE UNIT WAS TRIGGERED BY ATTACHING AND DETACHING THE RING MULTIPLE TIMES. REPRESENTATIVE STATED THAT UPON RESTART, THE PHANTOM TOUCH DISAPPEARED, AND THE SCREEN WAS FULLY FUNCTIONAL. PER ADDITIONAL INFORMATION RECEIVED ON 20-JUN-2022, THE SENSICA DEVICE WAS PULLED FROM THE FLOOR WITH A DO NOT USE STICKER, WITH NO ADDITIONAL DETAIL. THE UNIT WAS THEN GIVEN TO BD REPRESENTATIVE TO INVESTIGATE, THEY BROUGHT THE UNIT TO OUR CONFERENCE ROOM AND STARTED A MONITORING SESSION TO TRY IT OUT AND SEE IF IT WORKED. THEY ATTEMPTED TO ADD SOME WEIGHT TO SEE IF THE DEVICE WAS RECORDING CORRECTLY. AT FIRST, THEY TRIGGERED A SUDDEN INCREASE POSSIBLE ARTIFACT ALARM, AND REMOVED THE WEIGHT DURING STABILIZATION. THE DEVICE STABILIZATION ENDED AND DISPLAYED 0 ML. WHILE LOOKING OVER THE DEVICE, WE THEY TILTED IT AND TRIGGERED THE TILT ALARM A FEW TIMES. THEY ADDED SOME FLUID TO THE BAG, AND WAS ABLE TO INCREASE IT TO APPROXIMATELY 15 ML. THERE WAS A RANDOM JUMP UP TO ABOUT 69 ML THAT THEY CANNOT  COULD NOT ACCOUNT FOR. THE HOUR ENDED, AND THE DEVICE DISPLAYED ONLY THE NEW CURRENT HOUR. THEY ADDED ABOUT 10 ML WHICH IT READ AND CHECKED THE DATA SCREEN AND THE DATA FROM THE PREVIOUS HOUR WAS STILL PRESENT. WHEN RETURNING TO THE MAIN SCREEN IT STILL DID NOT SHOW THE FIRST PARTIAL HOUR. ONCE THE HOUR WAS UP, THE DEVICE CREATED A NEW HOUR AND STARTED DISPLAYING THE FIRST PARTIAL HOUR AS WELL (NEW HOUR WITH OLD MISSING HOUR).

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE COULD BE SOFTWARE ERROR. HOWEVER, THIS COULD NOT BE CONFIRMED. 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: ¿GENERAL WARNINGS MEDICAL ELECTRICAL EQUIPMENT REQUIRES SPECIAL PRECAUTIONS REGARDING ELECTROMAGNETIC COMPATIBILITY. (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. THE USE OF TRANSDUCERS AND CABLES OTHER THAN THOSE SPECIFIED, WITH THE EXCEPTION OF TRANSDUCERS AND CABLES SOLD AS REPLACEMENT PARTS, MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE BD SENSICA¿ URINE OUTPUT SYSTEM. THE BD SENSICA¿ URINE OUTPUT SYSTEM IS DESIGNED TO BE USED WITH ANY BARD¿ FOLEY CATHETER AND UROLOGICAL DISPOSABLES CONNECTED TO ANY STANDARD URINE DRAINAGE BAG (2000 OR 2500 ML), WITH OR WITHOUT A URINE METER. IF USING A 400-SERIES TEMPERATURE-SENSING FOLEY CATHETER, SEE PRODUCT INSTRUCTIONS FOR USE FOR MRI COMPATIBILITY. REFER TO FOLEY CATHETER INSTRUCTIONS FOR USE FOR INDICATIONS AND FURTHER PRODUCT INFORMATION. IF USING A 400-SERIES TEMPERATURE-SENSING FOLEY CATHETER, THE OPERATOR IS RESPONSIBLE FOR ENSURING THE COMPATIBILITY OF THE TEMPERATURE SENSING FOLEY CATHETER TO THE BD SENSICA¿ URINE OUTPUT SYSTEM AND ITS ACCESSORIES. INCOMPATIBLE COMPONENTS CAN RESULT IN DEGRADED PERFORMANCE. NO MODIFICATION OF THE BD SENSICA¿ URINE OUTPUT SYSTEM OR ANY OF ITS ACCESSORIES IS ALLOWED. 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.¿ CORRECTION: H. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.