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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICAUOTEMPCABLE
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C.R. BARD, INC. (COVINGTON) -1018233 SENSICAUOTEMPCABLE Back to Search Results
Model Number SCCS1002
Device Problem Erratic or Intermittent Display (1182)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2022
Event Type  malfunction  
Event Description
It was reported that the sensica device was exhibiting unusually high and low temperature values.Representative documented a picture of the screen with the evidence of these high and low values.Also pulled the log files from the unit.Temperature keys were also tested on the unit, there was good correlation between expected versus measured values.But with the 37c monoplug temperature key plugged in the reported value of the temperature key appeared to fluctuate while moving the temperature cable around 0.2 to 0.4c.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
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 sensica device was exhibiting unusually high and low temperature values.Representative documented a picture of the screen with the evidence of these high and low values.Also pulled the log files from the unit.Temperature keys were also tested on the unit, there was good correlation between expected versus measured values.But with the 37c monoplug temperature key plugged in the reported value of the temperature key appeared to fluctuate while moving the temperature cable around 0.2 to 0.4c.
 
Event Description
It was reported that the sensica device was exhibiting unusually high and low temperature values.Also pulled the log files from the unit.Temperature keys were also tested on the unit, there was good correlation between expected versus measured values.But with the 37c monoplug temperature key plugged in the reported value of the temperature key appeared to fluctuate while moving the temperature cable around 0.2 to 0.4c.
 
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 part geometry.However this cannot be confirmed.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: ¿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.¿ 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 device was not returned.
 
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Brand Name
SENSICAUOTEMPCABLE
Type of Device
SENSICAUOTEMPCABLE
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 Key13562066
MDR Text Key286022632
Report Number1018233-2022-00725
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSCCS1002
Device Catalogue NumberSBTC1005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/26/2022
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 Number1
Patient Outcome(s) Other;
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