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

Model Number	SBTS1001
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sensica device overreported the urine output.The device reads the total bag volume rather than the difference to the current hour.Approximately 350 ml were in the bag, and the device added 349 ml to the first 15minute hour block.It was also reported that the temperature would randomly drop to 26c or 30c and then come back to the actual temperature of 37.8c to 37.9c.Biomed downloaded the data logs to review, and the device rebooted and re-entered the patient case.After re-entering the patient case, the prior data was not displaying in the current hour or prior hours.The user navigated to the data history screen and then back to the main monitoring screen and once back to the main monitoring screen, the data was present on the device.However, in the prior hours when temperature was not connected to the device, the device was showing 0.0c or 470972.The patient continued the monitoring session with no further issues.Per follow-up information received via email on 11-feb-2022, the issue was found while using on patient and there was no impact.It was stated that the device indicates a large weight was placed around 319g and most likely a user hit resume on the device, since the confirmation happened after 5 seconds the tube was disconnected and then reconnected 15 seconds later which set the device into stabilization and after that, it seems to resume normal functionality.The event was confirmed by review of the case data and onsite personnel.The device continued the monitoring session.
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 overreported the urine output.The device reads the total bag volume rather than the difference to the current hour.Approximately 350 ml were in the bag, and the device added 349 ml to the first 15minute hour block.It was also reported that the temperature would randomly drop to 26c or 30c and then come back to the actual temperature of 37.8c to 37.9c.Biomed downloaded the data logs to review, and the device rebooted and re-entered the patient case.After re-entering the patient case, the prior data was not displaying in the current hour or prior hours.The user navigated to the data history screen and then back to the main monitoring screen and once back to the main monitoring screen, the data was present on the device.However, in the prior hours when temperature was not connected to the device, the device was showing 0.0c or 470972.The patient continued the monitoring session with no further issues.Per follow-up information received via email on 11-feb-2022, the issue was found while using on patient and there was no impact.It was stated that the device indicates a large weight was placed around 319g and most likely a user hit resume on the device, since the confirmation happened after 5 seconds the tube was disconnected and then reconnected 15 seconds later which set the device into stabilization and after that, it seems to resume normal functionality.The event was confirmed by review of the case data and onsite personnel.The device continued the monitoring session.
Additional Manufacturer Narrative
The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is temperature monitor pcba not receiving temperature data correctly.However this cannot be confirmed.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 device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "ifu for properly charging the device: when first using the sensica uo system, the internal back-up battery may require charging.Plug the system into a medical grade wall supply using the power cord provided, and allow a 20 hours to charge battery.To avoid battery drainage over time, is recommended to keep the system plugged into the wall during use whenever possible.The battery will recharge when the system is plugged into a wall supply.Cautions: during system start up and in general practice, plug the sensica uo system into a wall power supply whenever possible.After using the system on batter back-up, plug it back into the wall power supply recharging and to avoid system shut down due to a drained battery." the device was not returned.

• 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: 13691357
• Report Number: 1018233-2022-01101
• Device Sequence Number: 5009587
• Product Code: EXS
• UDI-Device Identifier: 00801741215650
• UDI-Public: 00801741215650
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/10/2022

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: SBTS1001
• Device Catalogue Number: SBTS1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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