The user facility stated that the t-pump was used with either a large or small rapr-round kit and that they did have lot numbers of the wraps that had been used.It was reported that the patient injury was classified as a minimal temporary harm.The injury was evaluated by a wound care consult who evaluated the patient approximately 31 hours after discovery.No treatment was deemed necessary for this patient.Allegedly blisters were observed throughout the patient's mid back and the top layer of skin was sloughing.The product was scrapped before an evaluation could take place.Although the product was not available for further evaluation, it could not be confirmed if this unit met specifications.Based on a conversation with a stryker associate engineering manager, this issue may be attributed to both the primary and backup limit thermostats experiencing a failure.It was identified by a stryker quality assurance engineer that for a burn to occur, the product would need to be greater than 44°c.Without a failure of the backup and primary thermostats, the highest temperature the t-pump can reach is 42°c.As such, this issue could not have occurred without a failure of both the primary and backup limit thermostats, however this could not be confirmed.Device not returned.
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