The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during setup, the shunt sensor experienced several calibration errors.This event was initially determined to be non-reportable.After receipt and eval of the actual sample, it was discovered that the shunt sensor leaked at the weld which caused the calibration errors.This eval discovery was found on (b)(6) 2014.No pt involvement as this occurred during setup.Product was changed out.Surgery was successfully completed.
|
Upon eval of the device, the complaint was confirmed.The complaint sample was returned and visually inspected.The initial attempts at calibrating the actual sample were met with errors.The unit was placed into a blood circuit to compare the outputs with the values measured by a blood-gas analyzer.During blood circulation, it was noticed that the shunt sensor was leaking.The calibration errors were due to the leak in the weld area being gross enough to cause a calibration failure.A review of the device history revealed no anomalies which would contribute to a leak.This unit was sufficiently cured and sealed to pass through a 100% leak test in-process.The root cause was identified to be shipping and handling paired with a decrease in mechanical integrity.(b)(4).
|