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

Catalog Number SCCS1002

Device Problem Intermittent Loss of Power (4016)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there had been a few ¿locked¿ screens on the sensica device.When the user connected a ring to the device, it shut down and restarted by itself.The user did not know at which point the device became locked, or if it locked up because they took the ring off.The user stated that the touch screen was not working, and they could not replicate the issue.The user mentioned that the measurement was off, and then a self-test with a ring was performed and the unit passed.

Event Description

It was reported that there had been a few ¿locked¿ screens on the sensica device.When the user connected a ring to the device, it shut down and restarted by itself.The user did not know at which point the device became locked, or if it locked up because they took the ring off.The user stated that the touch screen was not working, and they could not replicate the issue.The user mentioned that the measurement was off, and then a self-test with a ring was performed and the unit passed.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be software error/bugs.However, this cannot be confirmed.Screen displays ring disconnected.Uo recording has stopped.Unable to evaluate intermittent failure via picture.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.Unknown if device meet specifications, and was influenced by the reported failure.It is unknown if the device was in use on a patient.The serial number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿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.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.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.The sensica uo system for icu is designed for precise measurement using the disposable, sensica uo ring, which is part of the sensica uo patient ring kit.Each time the system is used with a new patient, a new sensica uo ring must be connected to the senica uo stand.The system software is designed to calibrate each time a new ring is attached to ensure accurate calculations of urine output volume.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.¿ the actual/suspected device was inspected.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13082801
• MDR Text Key: 284708386
• Report Number: 1018233-2021-08352
• 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: 04/27/2022

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 Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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