SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE OPTICAL SENSOR MISALIGNED ON THE SENSICA URINE OUTPUT SYSTEM. PER SAMPLE EVALUATION RESULTS RECEIVED ON 26MAY2023, IT WAS REPORTED THAT THE LOAD CELL GROUNDING WIRE NEEDED TO BE REPLACED.

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 UNIT WAS EVALUATED AND THE REPORTED ISSUE WAS CONFIRMED AS IT WAS NOTED THAT THE OPTICAL SENSOR MISALIGNED ON THE SENSICA URINE OUTPUT SYSTEM. THE MANUFACTURING OI SCCS1002X WAS UPDATED AS PART. ADDED GASKET FOAM TO OPTICAL SENSOR. LOAD CELL GROUND WIRE NEEDED TO BE REPLACED. REPLACED LOAD CELL GROUND WIRE. COMPLETED FINAL FUNCTIONAL TESTING. THE DEVICE DID NOT MEET SPECIFICATIONS, AND WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS NOT IN USE ON A PATIENT. THE DHR IS NOT REQUIRED AS THE DEVICE HAS UNDERGONE PREVIOUS SERVICING AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. BASED ON THE RESULTS OF THIS INVESTIGATIONS, NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "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 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. NOTE: IT IS HIGHLY RECOMMENDED TO KEEP THE SYSTEM PLUGGED INTO A WALL SUPPLY DURING USE AND TO COMPLETELY SHUT DOWN THE SYSTEM WHEN NOT IN USE. NOTE: DO NOT CONNECT ANY DEVICES TO THE BD SENSICA¿ URINE OUTPUT SYSTEM OTHER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE." 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 OPTICAL SENSOR MISALIGNED ON THE SENSICA URINE OUTPUT SYSTEM.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.