MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO SYSTEM

Model Number	SCCS1001
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the sensica device did not recognize the bag.Per follow up information received on (b)(6) 2022, the device was not used on the patient and would be sent in for repair.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the sensica device did not recognize the bag.Per follow up information received on (b)(6) 2022, the device was not used on the patient and would be sent in for repair.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be bag contact with peripheral object preventing full load transmission.However, this cannot be confirmed.The device was evaluated upon receipt.Load cell assembly was not receiving a signal from input weight and would not read bag, but could detect present of ring.The load cell assembly was replaced.Final functional testing was completed.Dhr is not required as the device has undergone previous servicing and therefore the reported event is not manufacturing related.Based on the results of this investigations, no additional action is required at this time.The instructions for use were found adequate and state the following: 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.Contraindications: there are no known contraindications for use with patients who have indwelling, urological catheters in place.Precautions: during system start up and in general practice, plug the bd sensica¿ urine output system into a wall power supply whenever possible.The system screen will dim when the system is unplugged to maximize battery life.After using the system on battery back-up, plug it back into the wall power supply for recharging and to avoid system shut down due to a drained battery.After removing a patient from urine output monitoring with the bd sensica¿ urine output system, shut down the system completely to avoid battery drainage while not in use.Low priority alarms may interrupt urine output monitoring and require user action to resume normal urine output monitoring functions.H11:section a through f - the information provided by bd represents all of 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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the sensica device did not recognize the bag.Per follow up information received on 07feb2022, the device was not used on the patient and would be sent in for repair.

• Brand Name: SENSICA UO SYSTEM
• Common Device Name: SENSICA UO SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13614954
• Report Number: 1018233-2022-00899
• Device Sequence Number: 12079606
• Product Code: EXS
• UDI-Device Identifier: 00801741215612
• UDI-Public: (01)00801741215612
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCCS1001
• Device Catalogue Number: SCCS1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 09/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown