Patient with hypoxic ischemic encephalopathy vs.Meconium aspiration syndrome on extracorporeal membrane oxygenation (ecmo device) for the third day.The patient's temperature dropped and began hemorrhaging.The accounts staff did not recognize the change in the baby's temperature since they were not monitoring continuously.The patient coded.The outcome is the patient did survive.The account alleged that the ecmo device water circulation stopped working causing the baby's temperature to drop.The device was removed from service and tested by the facility's biomed department.4 tests below were performed by facility's biomed and documented.Functional test confirmed unit hits target temperature - pass.Functional test confirmed unit circulates fluid- pass.Functional test confirmed unit resumes function after power interruption - pass.Functional test confirmed unit temp set point defaults to 37 when power is interrupted - pass.The accounts tests confirmed that the problem alleged could not be replicated.Per the csz operation & technical manual pg 47, 3 potential causes could have stopped the circulation of water.Shut-off valves on the connecting hose(s) are in the off position.Clogged water line.Pump not running.Per accounts testing these potential causes of water circulation disruption did not occur.The ecmo device used is past it useful life and it is unknown if the facility performs preventative maintenance on their devices.Csz has made multiple attempts to have the device returned for further evaluation.The investigation and testing confirms the device functioned as designed.If any new additional relevant information is identified, the complaint will be revaluated and characterized accordingly.Based on this information, no further action is required.Multiple attempts made for device rma.
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