SENSICA URINE OUTPUT SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE BIOMED STATED THAT THE SENSICA URINE OUTPUT DEVICE WAS SENT DOWN TO BIOMED WITH ISSUES STARTING A SESSION. IT WAS DETERMINED THAT THE DEVICE HAD A DAMAGED LOAD CELL WITH PINS POTENTIALLY BENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS LOGGING URINE OUTPUT INCORRECTLY AND TAKING A LONG TIME TO CONNECT TO START ONCE THE URINE BAG WAS CONNECTED. THEY HAVE ASKED FOR MORE TECHNICAL CLARIFICATION REGARDING THIS INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT THE BIOMED STATED THAT THE SENSICA URINE OUTPUT DEVICE WAS SENT DOWN TO BIOMED WITH ISSUES STARTING A SESSION. IT WAS DETERMINED THAT THE DEVICE HAD A DAMAGED LOAD CELL WITH PINS POTENTIALLY BENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS LOGGING URINE OUTPUT INCORRECTLY AND TAKING A LONG TIME TO CONNECT TO START ONCE THE URINE BAG WAS CONNECTED. THEY HAVE ASKED FOR MORE TECHNICAL CLARIFICATION REGARDING THIS INFORMATION.

Additional Manufacturer Narrative

THIS EVENT WAS CONFIRMED USE RELATED, NOT ATTRIBUTED TO A DEVICE MALFUNCTION. SUBMITTING THE INVESTIGATION DETAILS AS ADDITIONAL INFORMATION. THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS ROUGH HANDLING OF THE DEVICE. THE DEVICE WAS EVALUATED UPON RECEIPT. DEVICE WAS RECEIVED IN WITH DAMAGED LOAD CELL PINS. USE-RELATED. LOAD CELL WAS REPLACED. FOAM NEEDS TO BE APPLIED TO OPTICAL SENSOR. NEEDS NEW REVISION OF LOAD CELL GROUND CABLE. APPLIED FOAM TO OPTICAL SENSOR AND UPDATED DEVICE'S GROUND CABLE TO CURRENT REVISION. DEVICE PASSED ALL TESTING AFTER REPAIR. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE MANUFACTURING RELATED. THE INSTRUCTIONS-FOR-USE UNDER BAW0335274 REV 2 ARE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. CORRECTIONS: D, E, F, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.