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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO MONITOR ICU; SENSICA DEVICE Back to Search Results
Model Number SCCS1002
Device Problems Volume Accuracy Problem (1675); Component Misassembled (4004)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/20/2022
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 scale was not accurate on the sensica device.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is that the device assembled with an improper alignment, causing it to sit lower than normal.The device was evaluated upon receipt.Load cell was sitting lower than normal inside of front housing.Load cell was assembled with an improper alignment; causing it to sit lower than normal.This caused the load cell to "bottom out".The load cell assembly was replaced.Final functional testing was completed.The device did not meet specifications, and was influenced by the reported failure.It is unknown if the device was in use on a patient.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "1.1 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.1.4 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 actual/suspected device was evaluated.
 
Event Description
It was reported that the scale was not accurate on the sensica device.
 
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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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13515989
MDR Text Key285764882
Report Number1018233-2022-00552
Device Sequence Number1
Product Code EXS
UDI-Device Identifier00801741215773
UDI-Public00801741215773
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 09/02/2022
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 NumberSCCS1002
Device Catalogue NumberSCCS1002
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/20/2022
Initial Date FDA Received02/11/2022
Supplement Dates Manufacturer Received09/02/2022
Supplement Dates FDA Received09/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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