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

Model Number SCCS1002

Device Problem Volume Accuracy Problem (1675)

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.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 nurse had concerns regarding the reliability of the sensica monitor.Nurse wanted to check the reliability and acceptable error margin for the device and whether the reliability was impacted by low urine output.And hence nurse decided to measure the volume of urine emptied from the bag and compared it to the sensica device reading.Nurse described in one instance where the numbers differed by a couple hundred.In the other instance the bag was emptied and calibrated before going to a test.When the patient came back, the sensica said there was 4 ml of urine, but the bag indicated there were 14ml.Stated that this happened in a 6kg baby so, although 10 ml seems like a small amount, it can be significant.Nurse did not know if the difference was related to the 15 minute measurement display delay.While it was not unusual for small pediatric patients to not make enough urine to fill the bag, it was still possible that the bag could have been emptied resulting in the discrepancy in the first example.This could just be a case of nurses needing to let things go but it still would be nice to share the reliability data.

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 nurse had concerns regarding the reliability of the sensica monitor.Nurse wanted to check the reliability and acceptable error margin for the device and whether the reliability was impacted by low urine output.And hence nurse decided to measure the volume of urine emptied from the bag and compared it to the sensica device reading.Nurse described in one instance where the numbers differed by a couple hundred.In the other instance the bag was emptied and calibrated before going to a test.When the patient came back, the sensica said there was 4 ml of urine, but the bag indicated there were 14ml.Stated that this happened in a 6kg baby so, although 10 ml seems like a small amount, it can be significant.Nurse did not know if the difference was related to the 15 minute measurement display delay.While it was not unusual for small pediatric patients to not make enough urine to fill the bag, it was still possible that the bag could have been emptied resulting in the discrepancy in the first example.This could just be a case of nurses needing to let things go but it still would be nice to share the reliability data.

Event Description

It was reported that the nurse had concerns regarding the reliability of the sensica monitor.Nurse wanted to check the reliability and acceptable error margin for the device and whether the reliability was impacted by low urine output.And hence nurse decided to measure the volume of urine emptied from the bag and compared it to the sensica device reading.Nurse described in one instance where the numbers differed by a couple hundred.In the other instance the bag was emptied and calibrated before going to a test.When the patient came back, the sensica said there was 4 ml of urine, but the bag indicated there were 14ml.Stated that this happened in a 6kg baby so, although 10 ml seems like a small amount, it can be significant.Nurse did not know if the difference was related to the 15 minute measurement display delay.While it was not unusual for small pediatric patients to not make enough urine to fill the bag, it was still possible that the bag could have been emptied resulting in the discrepancy in the first example.This could just be a case of nurses needing to let things go but it still would be nice to share the reliability data.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is electrical power surge.However this cannot be confirmed.Nurse wanted to check the reliability and acceptable error margin for the device and whether the reliability was impacted by low urine output.And hence nurse decided to measure the volume of urine emptied from the bag and compared it to the sensica device reading.Nurse described in one instance where the numbers differed by a couple hundred.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.It is unknown if the device met specifications and whether the device 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.The instructions for use were found adequate and state the following: "ifu for properly charging the device: when first using the sensica uo system, the internal back-up battery may require charging.Plug the system into a medical grade wall supply using the power cord provided, and allow a 20 hours to charge battery.To avoid battery drainage over time, is recommended to keep the system plugged into the wall during use whenever possible.The battery will recharge when the system is plugged into a wall supply.Cautions: during system start up and in general practice, plug the sensica uo system into a wall power supply whenever possible.After using the system on batter back-up, plug it back into the wall power supply recharging and to avoid system shut down due to a drained battery." the device was not returned.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO 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: 13023148
• MDR Text Key: 285369637
• Report Number: 1018233-2021-08151
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

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: 11/30/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 02/26/2022
• Supplement Dates FDA Received: 03/23/2022
• 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
• Patient Weight: 6 KG