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

Model Number SCCS1002

Device Problem 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 has not been recorded in the sensica device (serial no - (b)(4) (serial no - unk).The nurse was receiving a question mark in the current hour.When the hour ends, the previous hourly measurement boxes in the left were converted to 0 for several hours (serial no - (b)(4) (serial no - unk).There were no error messages or alerts received.The patient was consistently producing 50 ml 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 unplugged the battery and allowed 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

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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 device was not returned.

Event Description

It was reported that for the past couple of hours the urine output has not been recorded in the sensica device (serial no - (b)(6)) (serial no - unk).The nurse was receiving a question mark in the current hour.When the hour ends, the previous hourly measurement boxes in the left were converted to 0 for several hours (serial no - (b)(6)) (serial no - unk).There were no error messages or alerts received.The patient was consistently producing 50 ml 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 unplugged the battery and allowed 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 SYSTEM
• 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: 13447917
• MDR Text Key: 287112494
• Report Number: 1018233-2022-00387
• 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: 07/20/2022

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: 01/14/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 07/20/2022
• 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