The reported issue was confirmed.The root cause of the reported issue was determined to be an user error in connecting the temperature cable to the incorrect temperature port.The user switched the cable to temperature port 1.The device did not meet specifications, and was influenced by the reported failure.The device was not 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.Although the product family is unknown.The instructions for use were found adequate and state the following: "the ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Ifu: connections guideline: the image of the control module system is provided in the ifu.Use only medivance approved cables and accessories with the arctic sun® temperature management system control module.Connect the fluid delivery line, patient temp 1 cable, patient temp 2 cable (optional) and fill tube to the back of the control module." 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.
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