SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT READING URINE OUTPUT.

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 DEVICE WAS NOT READING URINE OUTPUT.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. THE IDENTIFIED ROOT CAUSES IS ¿SOFTWARE ISSUES¿ AS IT WAS CONFIRMED THAT DUE TO CERTAIN SOFTWARE STEPS BEING INTERRUPTED, THAT UO WAS NOT BEING REPORTED OR CALCULATED CORRECTLY. FURTHERMORE, MULTIPLE CONTRIBUTING FACTORS WERE IDENTIFIED FOR THE UO ACCURACY ISSUE UNDER EVALUATION: ¿AMBIGUOUS IFU¿, ¿UNGRACEFUL SHUTDOWN,¿ ¿NOT FOLLOWING IFU,¿ ¿POWER ISSUES,¿ ¿SOFTWARE ANOMALY ASSESSMENT,¿ ¿PRODUCT ACQUISITION EVALUATION AND INTEGRATION," AND ¿ICU LAYOUT¿. HOWEVER, ALL THE CONTRIBUTING FACTORS ARE CORRELATED TO THE DISRUPTING SOFTWARE OPERATIONS PARTICULARLY WITH RELATION TO THE POWER SUPPLY AND UNGRACEFUL SHUTDOWNS. IT WAS A COMBINATION OF THE UNGRACEFUL SHUTDOWNS THAT FORCED THE SOFTWARE ISSUES TO BE IDENTIFIED WITH INCREASING PRECEDENCE. THESE ISSUES WERE PREVIOUSLY THOUGHT TO BE A LOWER RISK LEVEL, BUT THE CURRENT COMPLAINTS SHOW THAT THIS ASSESSMENT WAS INACCURATE. 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 KNOWN THAT THE DEVICE DID NOT MEET SPECIFICATIONS AND THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT. THE SERIAL NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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. CONTRAINDICATIONS: THERE ARE NO KNOWN CONTRAINDICATIONS FOR USE WITH PATIENTS WHO HAVE INDWELLING, UROLOGICAL CATHETERS IN PLACE. 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." 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.