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

Catalog Number SBTS1001

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 02/24/2022

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 temperature was initially reported as abnormally high in the sensica device by nurse.Mss observed that the patient temperature was 38.2 c on sensica.Mss then checked the cable connections and observed that the connections were correctly seated.The temperature foley was connected to the temperature measurement slot on the phillips monitor and the temperature read as 37.8c.Mss concluded that patient temperature on other measurement modalities were 36.8 c on axillary, 37.5 c on tympanic.A monoplug temperature key set for 37 c was connected to the phillips monitor - temperature read as 37.0 c.A spare monoplug adapter and temperature cable were attached to the temperature module but the sensica temperature still read as 38.2c.Mss concluded that temperature cable and monoplug were not responsible for high temperature reading.The next time mss was able to access the unit, the patient temperature on sensica read as 39.8 c.A 37 c monoplug temperature key was connected to the system.Sensica temperature displayed as 37.3 c.Based on the available information, mss concluded that the temperature module might be faulty.The monoplug 37c temperature key was attached to system.Sensica read temperature as 37.3 c.A spare temperature module was attached to the sensica and the patient temperature foley - sensica temperature read as 39.4 c.The patient temperature foley was attached to the phillips monitor - temperature read as 39.3 c.A spare temperature module from the same floor was swapped in and connected to the sensica and temperature foley.The 37 c monoplug temperature key was attached and read correctly as 37.0 c.Per follow up mail received on 08mar2022, there was no impact to the patient and no medical intervention required.

Event Description

It was reported that the temperature was initially reported as abnormally high in the sensica device by nurse.Mss observed that the patient temperature was 38.2 c on sensica.Mss then checked the cable connections and observed that the connections were correctly seated.The temperature foley was connected to the temperature measurement slot on the phillips monitor and the temperature read as 37.8c.Mss concluded that patient temperature on other measurement modalities were 36.8 c on axillary, 37.5 c on tympanic.A monoplug temperature key set for 37 c was connected to the phillips monitor - temperature read as 37.0 c.A spare monoplug adapter and temperature cable were attached to the temperature module but the sensica temperature still read as 38.2c.Mss concluded that temperature cable and monoplug were not responsible for high temperature reading.The next time mss was able to access the unit, the patient temperature on sensica read as 39.8 c.A 37 c monoplug temperature key was connected to the system.Sensica temperature displayed as 37.3 c.Based on the available information, mss concluded that the temperature module might be faulty.The monoplug 37c temperature key was attached to system.Sensica read temperature as 37.3 c.A spare temperature module was attached to the sensica and the patient temperature foley - sensica temperature read as 39.4 c.The patient temperature foley was attached to the phillips monitor - temperature read as 39.3 c.A spare temperature module from the same floor was swapped in and connected to the sensica and temperature foley.The 37 c monoplug temperature key was attached and read correctly as 37.0 c.Per follow up mail received on 08mar2022, there was no impact to the patient and no medical intervention required.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the product met specifications.The device was evaluated upon receipt.The sample was within the +-0.2 acceptable tolerance of the in-house temperature monitor module when tested on temperature keys.No repairs needed.It was unknown whether the device was influenced by the reported failure, however the device met specifications.The device was in use on a patient.The device history record review was not required as the reported event was unconfirmed.The instructions for use were found adequate and state the following: "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.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." 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 actual/suspected device was inspected.

• Brand Name: SENSICA UO SYSTEM
• Type of Device: SENSICA UO SYSTEM
• 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: 13839540
• MDR Text Key: 287555983
• Report Number: 1018233-2022-01463
• Device Sequence Number: 1
• Product Code: EXS
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SBTS1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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