The internal complaint file #(b)(4) has been logged for this incident for traceability.The device involved in this incident was not returned to belmont for investigation.This issue is obvious to the user as the patient's temperature values are continuously displayed on the screen.Other methods of thermoregulation can be used to warm the patient faster.Criticool setting was altered so that the re-warming would take place at the required times and not on the adult setting.Patient re-warmed with delay.The neonate was monitored throughout with skin and rectal temperature probes.Patient remains ventilated which is not a result of the delayed re-warming.The medical team and parents were informed.Within the criticool unit, patient mode is displayed in the top left section titled "patient".The selected patient mode is highlighted with a white box.In this scenario, adult mode is selected.To select a different mode, press the desired patient mode, either neonatal or adult.The new patient mode is highlighted with a white box.The user manual also contains the following note: "the neonatal and adult modes have different settings during operation".There was no report of patient injury as a result of the alleged incident.Belmont has contacted the user to request additional information and clinilogger data about the alleged incident.Without having the unit or clinilogger data for investigation, it is not possible to determine whether the unit malfunctioned or not.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
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Belmont followed up with the user facility and confirmed that there is no issue with the device.It was used on a neonatal patient while set in adult mode.There was no patient impact and the user has confirmed that they now have the device setup changed to neonatal.Clinilogger data was provided from the device and was reviewed by belmont engineering.It was identified that the rewarming rate was set to 0.2 c/hr, and the device rewarmed at this rate through the procedure.It was seen that the patient mode was set to adult, however this did not play any role in the rewarming rate of the patient.The device rewarmed at the set rate as designed.In order to avoid such an incident in future, belmont has given further instructions to the user facility on how to adjust the rewarming rate if they want to increase or decrease this rate.There was no device malfunction and no trend for this reported issue.Belmont will continue to monitor this issue moving forward.
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