SENSICA UO SYSTEM

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 CAPTURING HIGH URINE OUTPUT MEASUREMENT WHILE PATIENT WAS ON LASIX. THEY STATED THAT THE DEVICE WOULD NOT CAPTURE ALL OF THE URINE OUTPUT WHEN THE PATIENT WAS ON LASIX.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT CAPTURING HIGH URINE OUTPUT MEASUREMENT WHILE PATIENT WAS ON LASIX. THEY STATED THAT THE DEVICE WOULD NOT CAPTURE ALL OF THE URINE OUTPUT WHEN THE PATIENT WAS ON LASIX.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS EVALUATED UPON RECEIPT. SENSICA MEASURED/ADDED 300+ ML PHANTOM BOLAS OF UO WHEN PATIENT HAD LOW UO OUTPUT CONSISTENTLY PRIOR. NO REPAIRS WERE MADE. 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. THE DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. 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.¿ THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.