The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, it was noticed that the temperature probe was missing from the outlet of the oxygenator.No patient involvement as this occurred during prime.Product was changed out.Procedure was completed successfully.
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Evaluation of the returned sample confirmed that the thermistor on the oxygenator was missing, with no evidence of chemical residue within the port.Review of the product's device history record found that the specific serial number of the returned sample had passed final visual inspection, confirming that the thermistor had been present in the port at the time of packaging.It is likely that the thermistor had been inserted into the port of the oxygenator, but never dipped into the chemical to bond it into the port, allowing it to come loose and not be present at the time of use.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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