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 Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

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 buttons on the display screen of sensica monitor was frozen.

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 buttons on the display screen of sensica monitor was frozen.Per follow up information received via phone 05jan2022, initial reporter stated that the sensica device was frozen up and the nurse had to reboot the device in order to perform properly.Also stated that restarting the device deletes all the patient data that had been previously monitored and takes a significant amount time for the reboot, leaving the patient without urine monitoring until reboot had finished.Per follow up information received via phone on 10jan2022, initial reporter stated that was unsure of any impact to the patient from data being lost during reboot.Also stated that often times the nurse working with the patient would chart the data prior to restarting sensica but was unsure if the data was charted in that particular case.

Manufacturer Narrative

The reported issue was confirmed design related.The root cause of the reported issue is being investigated under capa.The device did not meet specifications, and was influenced by the reported failure.The device was in use on a patient.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Complaint addressed by existing capa.Hence labeling/packaging is not required.The device was not returned.

Event Description

It was reported that the buttons on the display screen of sensica monitor was frozen.Per follow up information received via phone 05jan2022, initial reporter stated that the sensica device was frozen up and the nurse had to reboot the device in order to perform properly.Also stated that restarting the device deletes all the patient data that had been previously monitored and takes a significant amount time for the reboot, leaving the patient without urine monitoring until reboot had finished.Per follow up information received via phone on 10jan2022, initial reporter stated that was unsure of any impact to the patient from data being lost during reboot.Also stated that often times the nurse working with the patient would chart the data prior to restarting sensica but was unsure if the data was charted in that particular case.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13087681
• MDR Text Key: 282775067
• Report Number: 1018233-2021-08429
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: (01)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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

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: 12/13/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 04/04/2022
• Supplement Dates FDA Received: 01/27/2022; 05/04/2022
• 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