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

Model Number SCCS1002

Device Problem Computer Software Problem (1112)

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

Event Date 11/30/2021

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 sensica monitor missed an hour.There was no 4pm (or) 5pm hour not displayed, despite the time being 5:08pm in the photos.The amount displayed as current hour would be counted as 5pm (or) 6pm volume.The nurse also noted that the large volume of output that was displayed in the 3rd 15 minute block of the 3pm (or) 4pm hour actually occurred during the 4pm (or) 5pm hour in the picture.The nurse noted that they did not think any urine was unaccounted , there was just no 4pm (or) 5pm displayed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bard represents all of 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 bard.

Event Description

It was reported that the sensica monitor missed an hour.There was no 4 pm (or) 5 pm hour not displayed despite the time being 5:08 pm in the photos.The amount displayed as current hour would be counted as 5 pm (or) 6 pm volume.The nurse also noted that the large volume of output that was displayed in the 3rd 15 minute block of the 3pm (or) 4pm hour actually occurred during the 4pm (or) 5pm hour in the picture.The nurse noted that did not think any urine was unaccounted for there was just no 4pm (or) 5pm displayed.Per follow up information received via email on 28dec2021 the patient was involved but unaffected as the nurse understood the information was incorrect and the problem fixed itself in the subsequent hour.The issue was an isolated incident and no resolution was needed.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is being investigated.There was no 4pm (or) 5pm hour not displayed, despite the time being 5:08pm in the photos.The amount displayed as current hour would be counted as 5pm (or) 6pm volume.The nurse also noted that the large volume of output that was displayed in the 3rd 15 minute block of the 3pm (or) 4pm hour actually occurred during the 4pm (or) 5pm hour in the picture.The nurse noted that did not think any urine was unaccounted for, there was just no 4pm (or) 5pm displayed.The two pictures that were sent showed two different volumes on the sensic screen but displayed the same time.Per follow up information received via email on (b)(6)2021, patient was involved but unaffected as the nurse understood the information was incorrect, problem fixed itself in the subsequent hour.The issue was an isolated incident and no resolution was needed.The serial number is unknown; therefore, the device history record could not be reviewed.Labeling review is not required because labeling could not have prevented this issue.Correction: d,h 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the sensica monitor missed an hour.There was no 4 pm (or) 5 pm hour not displayed despite the time being 5:08 pm in the photos.The amount displayed as current hour would be counted as 5 pm (or) 6 pm volume.The nurse also noted that the large volume of output that was displayed in the 3rd 15 minute block of the 3pm (or) 4pm hour actually occurred during the 4pm (or) 5pm hour in the picture.The nurse noted that did not think any urine was unaccounted for there was just no 4pm (or) 5pm displayed.Per follow up information received via email on (b)(6)2021 the patient was involved but unaffected as the nurse understood the information was incorrect and the problem fixed itself in the subsequent hour.The issue was an isolated incident and no resolution was needed.

• Brand Name: SENSICA UO ICU MONITOR
• Type of Device: SENSICA UO ICU MONITOR
• 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: 13048653
• MDR Text Key: 287014298
• Report Number: 1018233-2021-08220
• 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: 05/19/2022

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: Lay User/Patient
• Device Model Number: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 05/09/2022
• Supplement Dates FDA Received: 01/25/2022; 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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