The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the arterial thermistor on the oxygenator failed for it did not record temperature.As per the user facility, the cable was fine as they tested it on the venous thermistor port and it recorded the temperature.No known impact or consequence to patient.Product was not changed out.Procedure was completed successfully.
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Identification of evaluation codes 10, 11, 3331, 3259, 4307.Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The affected sample was returned for evaluation and found that the arterial thermistor to be non-functioning.A representative retention sample from the same product/lot number combination was tested and found to be functioning properly.The root cause of the issue has been determined to be a high insertion force during assembly of the thermistor into the oxygenator module coupled with exposure to extreme temperature fluctuations.A corrections and corrective actions are being implemented.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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