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

Model Number SCCS1002

Device Problem Volume Accuracy Problem (1675)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that the bag volume percentage of several sensica device was buggy and inaccurate.Biomed witnessed once where the bag was removed to move sensica device.It was stated that when the bag was placed back on the ring, the bag volume percentage dropped to 0 percent.A nurse complained that one sensica unit would turn on and immediately showed a low battery alarm and then it shut off.The representative investigated this issue and found that detaching and reattaching all the power connections resolved the issue.Another nurse complained that another sensica unit was not turning on.Biomed investigated the issue and found that detaching and reattaching all the power connections resolved the issue.Several nurses complained that the monoplug adapters were too tight and could not be easily disconnected, or often disconnected at all.Two nurses complained that the instant update alarm would be dismissed and repeatedly reappeared making an annoying amount of noise for both the clinician and the patient.It was also reported that several nurses commented during training that the ring removal tab was not clearly indicated and difficult to see, making it difficult to remove the ring.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

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 bag volume percentage of several sensica device was buggy and inaccurate.Biomed witnessed once where the bag was removed to move sensica device.It was stated that when the bag was placed back on the ring, the bag volume percentage dropped to 0 percent.A nurse complained that one sensica unit would turn on and immediately showed a low battery alarm and then it shut off.The representative investigated this issue and found that detaching and reattaching all the power connections resolved the issue.Another nurse complained that another sensica unit was not turning on.Biomed investigated the issue and found that detaching and reattaching all the power connections resolved the issue.Several nurses complained that the monoplug adapters were too tight and could not be easily disconnected, or often disconnected at all.Two nurses complained that the instant update alarm would be dismissed and repeatedly reappeared making an annoying amount of noise for both the clinician and the patient.It was also reported that several nurses commented during training that the ring removal tab was not clearly indicated and difficult to see, making it difficult to remove the ring.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause is an incorrectly coded calculation.However this cannot be confirmed.The device did not meet specifications, and 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: "introduction this manual provides the indications, contraindications, warnings, precautions, and instructions for use with the bd sensica¿ urine output system.Carefully read this manual in its entirety before using the bd sensica¿ urine output system.Failure to follow these instructions may result in improper use of this device.Contact customer service at +1.844.823.5433 with any questions about the information contained in this manual or about the operation and safety of the bd sensica¿ urine output system.1.2 indications for use 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.1.3 contraindications there are no known contraindications for use with patients who have indwelling, urological catheters in place.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." 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.H3 other text : the device was not returned.

Event Description

It was reported that the bag volume percentage of several sensica device was buggy and inaccurate.Biomed witnessed once where the bag was removed to move sensica device.It was stated that when the bag was placed back on the ring, the bag volume percentage dropped to 0 percent.A nurse complained that one sensica unit would turn on and immediately showed a low battery alarm and then it shut off.The representative investigated this issue and found that detaching and reattaching all the power connections resolved the issue.Another nurse complained that another sensica unit was not turning on.Biomed investigated the issue and found that detaching and reattaching all the power connections resolved the issue.Several nurses complained that the monoplug adapters were too tight and could not be easily disconnected, or often disconnected at all.Two nurses complained that the instant update alarm would be dismissed and repeatedly reappeared making an annoying amount of noise for both the clinician and the patient.It was also reported that several nurses commented during training that the ring removal tab was not clearly indicated and difficult to see, making it difficult to remove the ring.

• 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: 13010420
• MDR Text Key: 286516883
• Report Number: 1018233-2021-08089
• 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,Followup
• Report Date: 03/04/2022

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: 11/29/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 03/04/2022
• Supplement Dates FDA Received: 01/19/2022; 03/29/2022
• 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