The wrap has not been returned to belmont for evaluation.We have reached out to the user facility to obtain additional information about the case, and to determine whether the wrap is available to be returned for investigation.The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap.This may cause tearing and water leakage from the wrap." the following precaution is also provided: "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." without additional information, it is difficult to determine what occurred during the case at this time.Should additional information become available, a supplemental report will be submitted.
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The incident occurred three months prior to being reported, therefore the wrap in question was not available for investigation and the reported leak could not be confirmed.A sample of two infant curewraps were removed from production and tested on a criticool system for approximately two hours; no leaks were observed.A review of the manufacturing and leak test records for this lot number indicated no deviations or anomalies.All curewraps are 100% leak tested by the manufacturer prior to being released for shipment.The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap.This may cause tearing and water leakage from the wrap." the following precaution is also provided: "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." no report of patient harm.Belmont will continue to monitor and trend similar reports of this nature.
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