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

Model Number SCCS1002

Device Problems Display or Visual Feedback Problem (1184); Operating System Becomes Nonfunctional (2996)

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

Event Date 01/25/2022

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 the sensica device was not working and the only way the user could get it to work was by replacing the ring.There was no patient hooked up to the device and the charge nurse indicated that they could not restart the unit.Representative tried to restart the unit and verified that after pushing the power button, the graphic user interface screen came up asking if they were sure to restart and the yes option could not be pressed.Additionally, other buttons on the main graphic user interface were unresponsive.Further visual inspection of the screen indicated that there was a persistent phantom touch that showed up as a circle on the screen.The persistent phantom touch was determined to be the cause for why the screen was unresponsive.A restart of the unit was triggered by attaching and detaching the ring multiple times.Representative stated that upon restart, the phantom touch disappeared, and the screen was fully functional.

Manufacturer Narrative

The device was not returned.The reported issue was confirmed to be design related.The root cause of the reported issue is being investigated.The device did not meet specifications and was influenced by the reported failure.The device was not in use on a patient.The device history record review was not required as the complaint was addressed by existing capa.Labeling review was not required as the complaint was addressed by existing capa.The device was not returned.

Event Description

It was reported that the sensica device was not working and the only way the user could get it to work was by replacing the ring.There was no patient hooked up to the device and the charge nurse indicated that they could not restart the unit.Representative tried to restart the unit and verified that after pushing the power button, the graphic user interface screen came up asking if they were sure to restart and the yes option could not be pressed.Additionally, other buttons on the main graphic user interface were unresponsive.Further visual inspection of the screen indicated that there was a persistent phantom touch that showed up as a circle on the screen.The persistent phantom touch was determined to be the cause for why the screen was unresponsive.A restart of the unit was triggered by attaching and detaching the ring multiple times.Representative stated that upon restart, the phantom touch disappeared, and the screen was fully functional.

Manufacturer Narrative

The reported issue was confirmed design related.The identified root cause is the ¿firmware¿ of the sensica.Sensica firmware is not able to distinguish between human touch, cleaning liquid, and salt residue.In addition, with cleaning practices that increased more build up in salt residue and cleaning liquid it would cause phantom touches and screen responsivity to occur.This situation is then amplified with contributing factors such as ¿cleaning agents¿, ¿customers ifu oversights¿, ¿covid era¿ and ¿ifu not in alignment with cleaning validation¿.During the covid era period (early 2020- 2022) the frequency of cleaning was heavily increased.Healthcare professionals would clean the device each time they would enter the room according to their protocols.This increased frequency of cleaning and contributed to more residues build up which led to screen unresponsiveness.Additionally, the use of bleach based ¿cleaning agents¿ used by healthcare professionals contributed to more residues build up, because the use of bleach agents left larger amounts of residual salts after cleaning.Furthermore, ¿customers ifu oversights¿, in ifu (section 14, table 9), directed to wipe the screen and remove built up residue with a secondary clothe.This led to increased amount of salt residue because of the bleach agents and frequent cleaning practices.However, all the contributing factors stem from the firmware¿s recognition of sensitivity to capture accurate touch responses and prevent screen unresponsiveness.The sensica device was not working and the only way the user could get it to work was by replacing the ring.There was no patient hooked up to the device and the charge nurse indicated that they could not restart the unit.Representative tried to restart the unit and verified that after pushing the power button, the graphic user interface screen came up asking if they were sure to restart and the yes option could not be pressed.Additionally, other buttons on the main graphic user interface were unresponsive.Further visual inspection of the screen indicated that there was a persistent phantom touch that showed up as a circle on the screen.The persistent phantom touch was determined to be the cause for why the screen was unresponsive.A restart of the unit was triggered by attaching and detaching the ring multiple times.Representative stated that upon restart, the phantom touch disappeared, and the screen was fully functional.The following root causes/contributing factors were identified: 1.Firmware ¿ root cause 2.Cleaning agents ¿ contributing factor 3.Customer ifu oversights ¿ contributing factor 4.Covid era ¿ contributing factor 5.Ifu not in alignment with cleaning validation ¿ contributing factor" the instructions for use were found adequate and state the following: "do not sterilize any component of the bd sensica¿ urine output system.To clean the display touch screen, wipe with a soft cloth or use a germicide wipe such as super sani-cloth®.Do not spray harsh cleaners directly on the display touch screen.See section 14 for complete care and maintenance of the bd sensica¿ urine output system." h11: section a through f - the information provided by bd represents all 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 bd.

Event Description

It was reported that the sensica device was not working and the only way the user could get it to work was by replacing the ring.There was no patient hooked up to the device and the charge nurse indicated that they could not restart the unit.Representative tried to restart the unit and verified that after pushing the power button, the graphic user interface screen came up asking if they were sure to restart and the yes option could not be pressed.Additionally, other buttons on the main graphic user interface were unresponsive.Further visual inspection of the screen indicated that there was a persistent phantom touch that showed up as a circle on the screen.The persistent phantom touch was determined to be the cause for why the screen was unresponsive.A restart of the unit was triggered by attaching and detaching the ring multiple times.Representative stated that upon restart, the phantom touch disappeared, and the screen was fully functional.Per additional information received on 20jun2022, the arctic sun device was pulled from the floor with a do not use sticker, with no additional detail.The unit was then given to bd representative to investigate, they brought the unit to our conference room and started a monitoring session to try it out and see if it worked.They attempted to add some weight to see if the device was recording correctly.At first, they triggered a sudden increase possible artifact alarm, and removed the weight during stabilization.The device stabilization ended and displayed 0 ml.While looking over the device, we tilted it and triggered the tilt alarm a few times.They added some fluid to the bag, and was able to increase it to approximately 15 ml.There was a random jump up to about 69 ml that they cannot account for record.The hour ended, and the device displayed only the new current hour.They added about 10 ml which it read and checked the data screen and the data from the previous hour was still present.When returning to the main screen it still did not show the first partial hour.Once the hour was up, the device created a new hour and started displaying the first partial hour as well (new hour with old missing hour).

• 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: 13546480
• MDR Text Key: 285758945
• Report Number: 1018233-2022-00667
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: 00801741215773
• 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,Followup
• Report Date: 06/21/2022

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: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/31/2022; 06/21/2022
• Supplement Dates FDA Received: 04/27/2022; 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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