The reported issue was confirmed.The root cause of the reported issue is that the optical sensor is not situated correctly in the housing causing it to read incorrectly.Optical sensor is misaligned.The device did not meet specifications, and was influenced by the reported failure.It was unknown if the device was in use on a patient.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: "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." 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.
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