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

Model Number SCCS1002

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 11/22/2021

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 the nurse gave a lasix bolus to a patient, and about an hour later, the patient had bladder spasms and leaked a bunch around the catheter instead of it draining into the bag.Stated that they could see urine in the tubing, but it was stopped at the point where it was inserted into the side of the sensica machine.The nurse knew that this happened occasionally with the criticore machines, but that it usually drained when enough pressure was built up.According to the nurse, they ended up losing a large volume of uncharted urine, as well as the risk of injury or infection.Further they reported about another patient, who was given a lasix bolus, diuril bolus, and lasix infusion to achieve a urine output of 100 ml/hr.They were having little output until the nurse came in every 30 minutes and kept tipping and squeezing the tubing to get the urine to drain.The nurse then turned the patient over, disconnected the bag and tubing, turned off the power, and moved the sensica to the opposite side of the bed.When they reattached everything, it read the bag volume as 0% even though it had more than 500 ml in it, and it no longer read any volume as we tipped the tubing to drain into the bag.The nurse noticed a full 20 ml of fluid in the measuring apparatus and waited 5 minutes, but there was no added volume.The nurse tried reattaching the bag and tubing, but that did not help.They eventually emptied the bag and rehung it up, and it finally started reading again.The nurse did not know why this happened, but it very well could have led to increased diuretics because the volume was not being accounted for.Another nurse also noticed that the temperature on the sensica was reading 38.9 but the axillary temperature was 37.They stated that the patient was not febrile and was appearing to have a normal temperature to the touch.They also stated that they have heard from a couple other nurses as well that they have had readings close to 39 when other measurements are reading closer to 37.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.The root cause of the reported issue could not be determined.A potential root cause is a software issue.However this could not be confirmed.All good faith attempts have been made to obtain additional information.The outcome of the repair could not be determined at this time.The serial number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "the ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.The sensica uo system for icu is designed for precise measurement using the disposable, sensica uo ring, which is part of the sensica uo patient ring kit.Each time the system is used with a new patient, a new sensica uo ring must be connected to the senica uo stand.The system software is designed to calibrate each time a new ring is attached to ensure accurate calculations of urine output volume." 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 nurse gave a lasix bolus to a patient, and about an hour later, the patient had bladder spasms and leaked a bunch around the catheter instead of it draining into the bag.Stated that they could see urine in the tubing, but it was stopped at the point where it was inserted into the side of the sensica machine.The nurse knew that this happened occasionally with the criticore machines, but that it usually drained when enough pressure was built up.According to the nurse, they ended up losing a large volume of uncharted urine, as well as the risk of injury or infection.Further they reported about another patient, who was given a lasix bolus, diuril bolus, and lasix infusion to achieve a urine output of 100 ml/hr.They were having little output until the nurse came in every 30 minutes and kept tipping and squeezing the tubing to get the urine to drain.The nurse then turned the patient over, disconnected the bag and tubing, turned off the power, and moved the sensica to the opposite side of the bed.When they reattached everything, it read the bag volume as 0% even though it had more than 500 ml in it, and it no longer read any volume as we tipped the tubing to drain into the bag.The nurse noticed a full 20 ml of fluid in the measuring apparatus and waited 5 minutes, but there was no added volume.The nurse tried reattaching the bag and tubing, but that did not help.They eventually emptied the bag and rehung it up, and it finally started reading again.The nurse did not know why this happened, but it very well could have led to increased diuretics because the volume was not being accounted for.Another nurse also noticed that the temperature on the sensica was reading 38.9 but the axillary temperature was 37.They stated that the patient was not febrile and was appearing to have a normal temperature to the touch.They also stated that they have heard from a couple other nurses as well that they have had readings close to 39 when other measurements are reading closer to 37.

• 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: 12983146
• MDR Text Key: 284816158
• Report Number: 1018233-2021-07991
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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: 11/22/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 02/19/2022
• Supplement Dates FDA Received: 03/17/2022
• 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