SENSICA URINE OUTPUT SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT 1L OF URINE WAS OUT FROM FOLEY CATHETER THE PREVIOUS HOUR AND THE CATHETER BAG WAS EMPTIED PRIOR TO THAT HOUR IN THE SENSICA DEVICE. THERE WAS NOT 1L IN THE BAG, SO THE READING WAS WRONG. THE CATHETER TUBING WAS WRAPPED UP WITH THE BAG, SO THAT COULD HAVE POTENTIALLY BEEN MAKING THE DEVICE READ MORE URINE BASED ON WEIGHT.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE DEVICE WAS NOT RETURNED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE IS URINE CANNOT EASILY FLOW INTO URINE COLLECTION BAG DUE TO USER HANGS BAG ON RING WITHOUT REMOVING LOOPS/TWISTS IN TUBING. HOWEVER THIS CANNOT BE CONFIRMED. IT WAS 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 WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿TO PROPERLY STABILIZE THE SYSTEM FOR ACCURATE URINE OUTPUT MEASUREMENT, ALWAYS USE THE BD SENSICA¿ TUBE BAND POSITIONING STRIP PROVIDED IN THE BD SENSICA¿ RING KIT TO CORRECTLY POSITION THE TUBE BAND ON THE DRAINAGE TUBING. INSERT THE DRAINAGE TUBING IN THE TUBE HOLDER WITH THE TUBE BAND IN THE TUBE HOLDER WINDOW. THE BAND SHOULD BE PERMANENTLY ATTACHED TO THE DRAINAGE TUBING USING THE PROVIDED PEEL-OFF ADHESIVE BACKING. WHEN REMOVING THE BAG FROM THE RING FOR ANY REASON, SIMPLY PULL THE TUBING OUT OF THE TUBE HOLDER. WHEN RE-HANGING THE BAG, REINSERT THE TUBING INTO THE TUBE HOLDER WITH THE TUBE BAND IN THE TUBE HOLDER WINDOW. DO NOT TWIST OR KINK TUBING AT ANY TIME DURING USE. THE TUBE BAND POSITIONING STRIP DOES NOT NEED TO BE APPLIED WHEN USING A DRAINAGE BAG THAT COMES WITH PRE-MARKED TUBING. DURING OPERATION, KEEP DEVICE STAND LEVEL ON THE FLOOR TO AVOID TIPPING THE UNIT OVER AND DAMAGING SYSTEM COMPONENTS. ADDITIONALLY, THE DEVICE STAND SHOULD BE KEPT LEVEL DURING A MONITORING SESSION AS TILTING OF THE DEVICE MAY IMPACT THE ACCURACY OF URINE OUTPUT MEASUREMENTS.¿ 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 1L OF URINE WAS OUT FROM FOLEY CATHETER THE PREVIOUS HOUR AND THE CATHETER BAG WAS EMPTIED PRIOR TO THAT HOUR IN THE SENSICA DEVICE. THERE WAS NOT 1L IN THE BAG, SO THE READING WAS WRONG. THE CATHETER TUBING WAS WRAPPED UP WITH THE BAG, SO THAT COULD HAVE POTENTIALLY BEEN MAKING THE DEVICE READ MORE URINE BASED ON WEIGHT.

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.