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

Catalog Number SCCS1002

Device Problems Computer Software Problem (1112); Computer Operating System Problem (2898)

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

It was reported that for the past couple of hours the urine output had not been recorded in the sensica device.The nurse was receiving a question mark in the current hour.When the hour ends, the previous hourly measurement boxes to left convert to 0 for several hours.There were no error messages or alerts received.The patient was consistently producing 50 mls or greater for the past 4 hours.The nurse had attempted to remove the tubing from the tube holder and replaced it.There were no alerts received for the machine not recognizing the tubing.Nurse was currently unplugging the battery and allowing the machine to die.The nurse would restart the machine to see if the machine was recording when restarted.The nurse also stated that they were aware of a similar issue on another sensica device that was addressed by rebooting the device.It was stated that the nurse rebooted the system and the device continued working.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The device was not returned.The reported issue was confirmed.The device did not meet specifications and was influenced by the reported failure.The device was in use on a patient.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: f, 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.

Event Description

It was reported that for the past couple of hours the urine output had not been recorded in the sensica device.The nurse was receiving a question mark in the current hour.When the hour ends, the previous hourly measurement boxes to left convert to 0 for several hours.There were no error messages or alerts received.The patient was consistently producing 50 mls or greater for the past 4 hours.The nurse had attempted to remove the tubing from the tube holder and replaced it.There were no alerts received for the machine not recognizing the tubing.Nurse was currently unplugging the battery and allowing the machine to die.The nurse would restart the machine to see if the machine was recording when restarted.The nurse also stated that they were aware of a similar issue on another sensica device that was addressed by rebooting the device.It was stated that the nurse rebooted the system and the device continued working.

• 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: 13448002
• MDR Text Key: 285460925
• Report Number: 1018233-2022-00388
• Device Sequence Number: 1
• Product Code: EXS
• 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: 05/10/2022

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 Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/31/2022
• 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