SENSICA URINE OUTPUT SYSTEM

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS THAT THE OPTICAL SENSOR IS NOT SITUATED CORRECTLY IN THE HOUSING CAUSING IT TO READ INCORRECTLY. THE DEVICE WAS EVALUATED UPON RECEIPT. OPTICAL SENSOR NEEDS A FOAM GASKET. THE MANUFACTURING WAS UPDATED. GASKET FOAM WAS ADDED. COMPLETED FINAL FUNCTIONAL TESTING. DURING FIELD ACTION UPDATE DEVICE DISPLAYED ERROR CODE AND WOULD NOT COMPLETE A RE-IMAGING. SOFTWARE WAS UPDATED. REPLACED THE BASE FEET AND BASE LABEL. COMPLETED FINAL FUNCTIONAL TESTING. THE DEVICE DID NOT MEET SPECIFICATIONS AND THE PRODUCT WAS INFLUENCED BY THE REPORTED FAILURE. PATIENT INVOLVEMENT IS UNKNOWN. 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: "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 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. SECTION 1: INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, AND CAUTIONS 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. CONTACT CUSTOMER SERVICE AT +1.844.823.5433 WITH ANY QUESTIONS ABOUT THE INFORMATION CONTAINED IN THIS MANUAL OR ABOUT THE OPERATION AND SAFETY OF THE BD SENSICA¿ URINE OUTPUT SYSTEM. 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 7 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." CORRECTION: D,F,H. H11: SECTION A THROUGH F - 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED

Description of Event or Problem

IT WAS REPORTED THAT THE OPTICAL SENSOR FAILED IN SENSICA DEVICE. READ ACTUATED WHEN NO TUBE PRESENT. PER WO UPDATE ON 02FEB2023, RE-IMAGING ERROR CODE. DURING FIELD ACTION UPDATE DEVICE DISPLAYED ERROR CODE AND WOULD NOT COMPLETE A RE-IMAGING

Description of Event or Problem

IT WAS REPORTED THAT THE OPTICAL SENSOR FAILED IN SENSICA DEVICE. READ ACTUATED WHEN NO TUBE PRESENT. PER WO UPDATE ON 02 FEB 2023, RE-IMAGING ERROR CODE. DURING FIELD ACTION UPDATE DEVICE DISPLAYED ERROR CODE AND WOULD NOT COMPLETE A RE-IMAGING

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.