There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).(b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the sorin heater-cooler system 3t was not pumping on the patient circuit during in-service.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.The customer clarified at that time that the issue they had with the unit was that it was not warming to 37 degrees.The technician tested the system by switching between cold and hot.The system displayed an error when switching to hot and stopped pumping.However, clearing the error resolved the issue and the system began functioning as expected.The service representative checked the calibration and tested the system again without issue.The reported issue was not reproduced; the unit was able to reach and maintain the set temperature.As the issue could not be confirmed, a root cause was not determined and no corrective actions were identified.A review of the dhr has not yet been performed.A follow-up report will be submitted upon completion of the dhr review.Evaluated on site by sorin service rep.
|