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

Model Number SCCS1002

Device Problem Restricted Flow rate (1248)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

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.

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 when 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 reattached 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 device 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.No medical intervention was reported.

Manufacturer Narrative

The reported issue was inconclusive.No sample was returned for evaluation.The root cause of the reported issue could not be determined.A potential root cause is incorrect part geometry.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 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.¿¿indications: the bd sensica¿ urine output system is an automated system for continuous monitoring of urine output (uo) and core bladder temperature when connected to a temperature-sensing foley catheter.Target population: the bd sensica¿ urine output system is intended for bedside monitoring of urine output for any patient with an indwelling, urological catheter, drainage tubing and collection bag, typically in critical care settings or where close monitoring of urine output is desired.The bd sensica¿ urine output system is also intended for monitoring core bladder temperature when used with the bd sensica¿ temperature monitor module and a bd 400 series temperature-sensing foley catheter or equivalent.General warnings medical electrical equipment requires special precautions regarding electromagnetic compatibility (emc) and needs to be installed and put into service according to the emc information provided in the charts at the end of these instructions for use (appendix a).Portable and mobile radiofrequency (rf) communications equipment can affect medical electrical equipment.The bd sensica¿ urine output system should not be stacked with other equipment.The bd sensica¿ urine output system has a degree of protection against electric shock of applied parts classified as type bf.This device is classified as an iec class i device.When using class 1 xp power model number: alm65us12 power supply, to avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.Do not immerse or submerge the bd sensica¿ urine output stand, display monitor, ring, temperature monitor module, temperature sensor cables, or monoplug adapter in water or other liquids.Do not pour liquids over the display monitor, ring, temperature monitor, cables or monoplug adapter.If liquids accidentally spill onto the device(s), wipe off liquid with soft cloth as soon as possible.See section 14 for complete care instructions.This device is not suitable for use in the presence of flammable mixtures.This device is not suitable for use in oxygen rich environments.The use of transducers and cables other than those specified, with the exception of transducers and cables sold as replacement parts, may result in increased emissions or decreased immunity of the bd sensica¿ urine output system.The bd sensica¿ urine output system is designed to be used with any bard¿ foley catheter and urological disposables connected to any standard urine drainage bag (2000 or 2500 ml), with or without a urine meter.If using a 400-series temperature-sensing foley catheter, see product instructions for use for mri compatibility.Refer to foley catheter instructions for use for indications and further product information.If using a 400-series temperature-sensing foley catheter, the operator is responsible for ensuring the compatibility of the temperature sensing foley catheter to the bd sensica¿ urine output system and its accessories.Incompatible components can result in degraded performance.No modification of the bd sensica¿ urine output system or any of its accessories is allowed.Warning: this product can expose you to di(2-ethylhexyl) phthalate (dehp), which is known to the state of california to cause cancer and birth defects or other reproductive harm.¿ 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 when 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 reattached 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 device 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.No medical intervention was reported.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12981712
• MDR Text Key: 287013547
• Report Number: 1018233-2021-07951
• 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: 06/09/2022

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: 12/12/2021
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/10/2022
• 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