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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO MONITOR ICU; SENSICA DEVICE
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C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO MONITOR ICU; SENSICA DEVICE Back to Search Results
Model Number SCCS1002
Device Problem Operating System Becomes Nonfunctional (2996)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
It was reported that the sensica devices would crash and reboot when attempting to start a patient monitoring session or would continually crash or reboot before loading to the terms and agreements screen.This would only occur shortly after connecting the ring and also when leaving the ring connected.
 
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 the sensica devices would crash and reboot when attempting to start a patient monitoring session or would continually crash or reboot before loading to the terms and agreements screen.This would only occur shortly after connecting the ring and also when leaving the ring connected.Per additional information received on 13jun2022, it was stated that when troubleshooting, this device would power on and load to the splash screen and the initial screen where a user creates a new patient session without issue.User left the device alone for a few minutes to see if it would crash or reboot, but nothing had happened.Then user attempted to create a new patient session, and about 15 seconds after adding the ring they did not even attempt to add the tube or bag, the device crashed and rebooted.User repeated this a few times with the same results each time.It was also noticed that if the ring was left on while the sensica rebooted, the device would continuously reboot and did watch it reboot at least 4 times in a row.The device would crash and reboot again every time right before the user license terms or agreements box appeared.Another observation was that the error telling users to remove the ring while the sensica booted up never once appeared and it should have appeared (pr# 5387204).If they removed the ring at any point, the device would boot normally to the splash screen again.Next, from the splash screen, they run the sensica utility app on the device.The utility app ran without issue until they added the ring.After connecting the ring and clicking read on the measurements tab, the device immediately crashed and rebooted by itself again in the same manner described above.It seemed there was some issue between the hardware and software on the ring because the problem so far only occurred right after the ring was connected.An example that would cause the device to crash or reboot if it failed would be if the i2c signal to the ring's electrically erasable programmable read-only memory (eprom) was disconnected, or the software failed to recognize the connection.In this case, the watchdog should crash and reboot the device.They did not see any visible damage to the gold pins and did not capture the gold pins in videos of this issue.This device was placed aside and would need to be shipped out for service and repair.
 
Manufacturer Narrative
The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is part geometry.However this cannot be confirmed.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.It is unknown if the device met specifications and whether the device was influenced by the reported failure.The device was in use on a patient.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.
 
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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 Key13664634
MDR Text Key286559641
Report Number1018233-2022-01032
Device Sequence Number1
Product Code EXS
UDI-Device Identifier00801741215773
UDI-Public00801741215773
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 07/27/2022
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 Model NumberSCCS1002
Device Catalogue NumberSCCS1002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2022
Initial Date FDA Received03/03/2022
Supplement Dates Manufacturer Received07/28/2022
Supplement Dates FDA Received08/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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