SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE URINE OUTPUT WAS NOT MEASURED WHEN THE BAG WAS REMOVED AND LATER WAS HANGED AGAIN ON THE SENSICA AFTER MOVING THE PATIENT IN THE BED. ANECDOTAL REPORT FROM NURSE ON WARD 7G STATED THAT THIS HAD HAPPENED TO OTHERS ON 7G AS WELL, BUT THERE WERE NO ACTIVE CASES DURING THEIR TIME THERE. NURSE SAID THAT WHILE THEY CLEANED THE PATIENT OR MOVED THE PATIENT AROUND, THEY WOULD REMOVE THE BAG FROM THE SENSICA FOR 1 MIN OR MAYBE 20-30 MINS AND THE BAG WOULD STILL COLLECT URINE DURING THIS TIME. HOWEVER, AFTER PLACING THE BAG BACK ON THE SENSICA, THEY SAID THAT THE SENSICA WOULD NOT MEASURE THE NEW AMOUNT OF URINE ADDED TO THE BAG DURING THIS TIME. IT WAS STATED THAT THIS REPORTEDLY HAPPENED AT LEAST A FEW TIMES. BECAUSE OF THIS, NURSE SAID THAT THEY WOULD CLAMP THE CATHETER OR TUBING SO THE URINE OUTPUT WOULD NOT BE LOST BY SENSICA WHILE THE BAG WAS REMOVED. SOME OTHER NURSES ON 7G APPARENTLY USE THIS METHOD TOO.

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.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE IS A CALCULATION CODING ERROR. HOWEVER THIS CANNOT BE CONFIRMED. ANECDOTAL REPORT FROM NURSE ON WARD 7G STATED THAT THIS HAD HAPPENED TO OTHERS ON 7G AS WELL, BUT THERE WERE NO ACTIVE CASES DURING THEIR TIME THERE. NURSE SAID THAT WHILE THEY CLEANED THE PATIENT OR MOVED THE PATIENT AROUND, THEY WOULD REMOVE THE BAG FROM THE SENSICA FOR 1 MIN OR MAYBE 20-30 MINS AND THE BAG WOULD STILL COLLECT URINE DURING THIS TIME. HOWEVER, AFTER PLACING THE BAG BACK ON THE SENSICA, THEY SAID THAT THE SENSICA WOULD NOT MEASURE THE NEW AMOUNT OF URINE ADDED TO THE BAG DURING THIS TIME. IT WAS STATED THAT THIS REPORTEDLY HAPPENED AT LEAST A FEW TIMES TO HER. BECAUSE OF THIS, NURSE SAID THAT THEY WOULD CLAMP THE CATHETER OR TUBING SO THE URINE OUTPUT WOULD NOT BE LOST BY SENSICA WHILE THE BAG WAS REMOVED. SOME OTHER NURSES ON 7G APPARENTLY USE THIS METHOD TOO. 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 UNKNOWN IF THE DEVICE DID MEET SPECIFICATIONS AND WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS IN USE ON A PATIENT. THE SERIAL NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "'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. ""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. 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. 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: G 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 DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE URINE OUTPUT WAS NOT MEASURED WHEN THE BAG WAS REMOVED AND LATER WAS HANGED AGAIN ON THE SENSICA AFTER MOVING THE PATIENT IN THE BED. ANECDOTAL REPORT FROM NURSE ON WARD 7G STATED THAT THIS HAD HAPPENED TO OTHERS ON 7G AS WELL, BUT THERE WERE NO ACTIVE CASES DURING THEIR TIME THERE. NURSE SAID THAT WHILE THEY CLEANED THE PATIENT OR MOVED THE PATIENT AROUND, THEY WOULD REMOVE THE BAG FROM THE SENSICA FOR 1 MIN OR MAYBE 20-30 MINS AND THE BAG WOULD STILL COLLECT URINE DURING THIS TIME. HOWEVER, AFTER PLACING THE BAG BACK ON THE SENSICA, THEY SAID THAT THE SENSICA WOULD NOT MEASURE THE NEW AMOUNT OF URINE ADDED TO THE BAG DURING THIS TIME. IT WAS STATED THAT THIS REPORTEDLY HAPPENED AT LEAST A FEW TIMES. BECAUSE OF THIS, NURSE SAID THAT THEY WOULD CLAMP THE CATHETER OR TUBING SO THE URINE OUTPUT WOULD NOT BE LOST BY SENSICA WHILE THE BAG WAS REMOVED. SOME OTHER NURSES ON 7G APPARENTLY USE THIS METHOD TOO.