The customer reported that the companion 2 driver exhibited irregular left pressure waveforms while supporting a patient.The customer also reported that the patient's systolic blood pressure was at 120 and the companion 2 driver's output pressure was set at 200 millimeters of mercury (mmhg).The customer also reported that the patient's lab values reflected hemolysis on the day of the reported event.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.Visual inspection of the driver's external components revealed no anomalies.The patient data file was copied and reviewed, confirming the left pressure incorrect alarms as reported by the customer.During failure investigation testing, the customer-reported left pressure incorrect alarm was duplicated.The root cause was a malfunction of the left electronic pressure regulator.The left electronic pressure regulator was taken out of service and replaced.Syncardia has initiated a corrective action (capa) to address the issue with electronic pressure regulators in relation to pressure incorrect alarms the investigation is in process.Potential corrective actions will be evaluated when the root cause investigation has been completed.It is unlikely that the higher left pressure would be the cause of the patient's hemolysis reported by the customer.Once the driveline pressure increases to the point of achieving the full eject flag, the diaphragm is in the full "up" position.When this occurs, any further increase in pressure would be isolated to the diaphragm of the patient's tah-t and is not transferred to the patient's blood.Despite the customer-reported left pressure incorrect alarms, risk to the patient was low because the driver continued to perform its life-sustaining functions.The driver was serviced and passed all functional and performance testing prior to being released to finished goods.Syncardia has completed its evaluation of this complaint and is closing this file.
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