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

Model Number SCCS1002E

Device Problem False Alarm (1013)

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

Event Date 02/08/2022

Event Type  malfunction  

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 sensica device showed an error on the screen warning that the device was not connected to the power supply.This was incorrect as the device was plugged in and receiving power and they double checked all the easy points of failure including if the power brick had a loose connection to the 115v power cord, of if the 12v dc connection was loose where it connected to the machine.Representative confirmed the power brick was receiving power and that the cord was providing 12v at the end of the connector where it would connect to the machine.The sensica device itself seemed to have the error where it does not recognize the machine was connected to power and there was no visible damage anywhere to connection points either.The device also remained operable for more than 1.5hrs with this message displayed, suggesting that it was receiving power (otherwise the batteries would run out).However, during this time, the screen continued to display the warning box prominently on the front of the screen warning that the device was not connected to power.They believed the error was somewhere inside the machine and not a function of a faulty power supply based on my own testing with a multi-meter.Per email response received on 04 april 2022, initial reporter stated that the issue was occurred on (b)(6) 2022 and was not found during patient use.The device was still having issues and wanted to send the device in for repair.

Event Description

It was reported that the sensica device showed an error on the screen warning that the device was not connected to the power supply.This was incorrect as the device was plugged in and receiving power and they double checked all the easy points of failure including if the power brick had a loose connection to the 115v power cord, of if the 12v dc connection was loose where it connected to the machine.Representative confirmed the power brick was receiving power and that the cord was providing 12v at the end of the connector where it would connect to the machine.The sensica device itself seemed to have the error where it does not recognize the machine was connected to power and there was no visible damage anywhere to connection points either.The device also remained operable for more than 1.5hrs with this message displayed, suggesting that it was receiving power (otherwise the batteries would run out).However, during this time, the screen continued to display the warning box prominently on the front of the screen warning that the device was not connected to power.They believed the error was somewhere inside the machine and not a function of a faulty power supply based on my own testing with a multi-meter.Per email response received on 04april2022, initial reporter stated that the issue was occurred on 08feb2022 and was not found during patient use.The device was still having issues and wanted to send the device in for repair.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is system does not properly display alarm or notification.However this cannot be confirmed.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.The device was not returned.

• Brand Name: SENSICA UO MONITOR ICU
• 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: 14180983
• MDR Text Key: 289874125
• Report Number: 1018233-2022-02799
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741219016
• UDI-Public: 00801741219016
• 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: 10/11/2022

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: SCCS1002E
• Device Catalogue Number: SCCS1002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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