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

Model Number SCCS1001

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

It was reported that the phantom added 11mls during the demo was a concern in the sensica device.Multiple bd representatives were there when this occurred, and this caught us all by surprise.There were mixed reviews from the team that witnessed this where they were certain the system was at rest with nothing touching it or going into the bag when 11mls showed up as added urine output.This could have been a situation where we had a finicky device but this seemed all too common with the previous experiences we¿ve had with sensica so we concluded that further testing needs to be observed in situations that include testing sensica at rest but actually treating it like nurses do in the intensive care unit and moving it from one side of the bed to another, transitioning them from bed to chair and see if the device only added urine output in these situations verses what we have seen like this instance that had happened before which was phantom additions of urine being added to the hourly output.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the phantom added 11mls during the demo was a concern in the sensica device.Multiple bd representatives were there when this occurred, and this caught us all by surprise.There were mixed reviews from the team that witnessed this where they were certain the system was at rest with nothing touching it or going into the bag when 11mls showed up as added urine output.This could have been a situation where we had a finicky device but this seemed all too common with the previous experiences we¿ve had with sensica so we concluded that further testing needs to be observed in situations that include testing sensica at rest but actually treating it like nurses do in the intensive care unit and moving it from one side of the bed to another, transitioning them from bed to chair and see if the device only added urine output in these situations verses what we have seen like this instance that had happened before which was phantom additions of urine being added to the hourly output.Per follow up information received on 27jul2022, there was no patient involvement as the issue occurred during demonstration.

Manufacturer Narrative

The root cause of the reported issue could not be confirmed.A potential root cause for the reported issue could be load cell overload.However, this cannot be confirmed.A device history review is not required as the serial number is unknown.Based on the results of this investigations, no additional action is required at this time.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." h11: section a through f - the information provided by bard 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 bard.

• Brand Name: SENSICA UO SYSTEM
• Type of Device: SENSICA DEVICE
• 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: 15121648
• MDR Text Key: 304334395
• Report Number: 1018233-2022-05827
• Device Sequence Number: 1
• Product Code: EXS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Model Number: SCCS1001
• Device Catalogue Number: SCCS1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other