SENSICA URINE OUTPUT SYSTEM
Received May 20, 2022 · Event occurred Apr 27, 2022
Report 1018233-2022-03958 · MDR key 14459492
Device
Generic name
Sensica Uo System
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
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 CRITICAL CARE UNIT (CCU) HAD ONE SENSICA DEVICE OUT OF SERVICE AND THE ISSUE WAS FAILURE TO SENSE THE FOLEY PROBE. THE DEVICE WAS SENT TO BIOMED BEFORE GETTING ANY DEVICE INFORMATION. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 06MAY2022, THE SENSICA RING WAS NOT BEING RECOGNIZED . AS PER THE FOLLOW UP INFORMATION RECEIVED ON 06MAY2022, THE SENSICA DEVICE WAS CHECKED BY BIOMED AND FOUND NO ISSUES WITH EITHER OF THE REPORTED EVENTS. THERE WERE NO REPAIRS NEEDED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS UNABLE TO BE DETERMINED, AS THE DEVICE WAS OPERATING APPROPRIATELY PER BIOMED EVALUATION. PER FOLLOW UP INFORMATION RECEIVED, THE SENSICA DEVICE WAS CHECKED BY BIOMED AND FOUND NO ISSUES WITH EITHER OF THE REPORTED EVENTS. THERE WERE NO REPAIRS NEEDED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. IT IS KNOWN THAT THE DEVICE DID MEET SPECIFICATIONS. HOWEVER, IT IS UNKNOWN IF THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE. PATIENT INVOLVEMENT IS UNKNOWN. THE DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED AS THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE MANUFACTURING RELATED. LABELING REVIEW WAS NOT PERFORMED AS THE REPORTED EVENT IS UNCONFIRMED. THE DEVICE WAS EVALUATED BY THE FACILITY¿S BIOMED.
Description of Event or Problem
IT WAS REPORTED THAT CRITICAL CARE UNIT (CCU) HAD ONE SENSICA DEVICE OUT OF SERVICE AND THE ISSUE WAS FAILURE TO SENSE THE FOLEY PROBE. THE DEVICE WAS SENT TO BIOMED BEFORE GETTING ANY DEVICE INFORMATION. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 06MAY2022, THE SENSICA RING WAS NOT BEING RECOGNIZED. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 06MAY2022, THE SENSICA DEVICE WAS CHECKED BY BIOMED AND FOUND NO ISSUES WITH EITHER OF THE REPORTED EVENTS. THERE WERE NO REPAIRS NEEDED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.