It was reported that during use of the 70 cc2 cable, the blood temperature (bt) was unstable from 48¿celsius to 10¿celsius.When the suspect cable was replaced, the issue was improved.No alarm or error message was observed.No patient injury was reported and there was no treatment given to patient due to this event.Patient demographics are unavailable.
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The 70cc2 cable was returned to be evaluated.The customer¿s report of blood temperature was unstable from 48 degrees c to 10 degrees c was confirmed.During testing, if the cable was moved or wiggled, the fault message ¿blood temp out of range (<31°c or >41°c)" was observed.The root cause was determined to be an intermittent disconnection of the cable.The device history record was reviewed with no related non-conformances found.With any hemodynamic monitoring, physiologic parameters can change quickly and dramatically.Physiologic parameters are used to base clinical treatment decisions.In this event, the blood temperature reading was out of range, which would cause an incorrect co value to be displayed.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make treatment decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
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