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 monitor of the sensica device was going back and forth on the bag volume estimate between ml and percent without anyone touching it.The nurse said that there was a grey circle in the top corner, but it wasn't always there.When they tried to access data screen it would open but then close out due to whatever glitch was happening and take them back to the home screen.The nurse stated that the device had been on a patient for 24 hours before this happened, they restarted the device, and it went away.Per follow-up information received via email on 01feb2022, the device issue was corrected by turning the device off and on, and functioned well after that.The patient was able to complete treatment.

Manufacturer Narrative

Upon further review, bd has determined this event is not reportable.The device was not returned.

Event Description

It was reported that monitor of the sensica device was going back and forth on the bag volume estimate between ml and percent without anyone touching it.The nurse said that there was a grey circle in the top corner, but it wasn't always there.When they tried to access data screen it would open but then close out due to whatever glitch was happening and take them back to the home screen.The nurse stated that the device had been on a patient for 24 hours before this happened, they restarted the device, and it went away.Per follow-up information received via email on 01feb2022, the device issue was corrected by turning the device off and on, and functioned well after that.The patient was able to complete treatment.

• 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: 13565291
• MDR Text Key: 290944334
• Report Number: 1018233-2022-00750
• 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
• Report Date: 04/06/2022

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: 02/19/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 05/06/2022
• 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