The customer reported that the freedom driver exhibited fluctuating low fill volumes while supporting a patient.The customer also reported that while the patient was preparing to leave the house and go to the emergency room, the freedom driver exhibited an irreversible fault alarm.The patient was subsequently switched to the backup freedom driver.When the patient arrived at the hospital, he was transferred to the companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited fluctuating fill volumes, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
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The customer reported that the freedom driver exhibited fluctuating low fill volumes while supporting a patient.The customer also reported that while the patient was preparing to leave the house and go to the emergency room, the freedom driver exhibited an irreversible fault alarm.The patient was subsequently switched to the backup freedom driver.When the patient arrived at the hospital, he was transferred to the companion 2 driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the interior of the driver revealed that the potentiometer used to adjust the primary motor beat rate was a non-specified component.The presence of this component in this driver is not related to this complaint.The non-specified potentiometer is functionally equivalent to the specified potentiometer.The potentiometer was replaced with a specified potentiometer.The driver then passed all final performance testing.Syncardia has initiated a corrective action (capa) to address the non-specified potentiometer issue.The capa is in process.Review of the alarm history (eeprom) data confirmed that the driver did not record a permanent fault alarm while supporting the patient and the customer-reported fault alarm and fill volume fluctuations were not able to be duplicated during functional testing.The driver passed all test requirements with no anomalies or alarms.The investigation concluded that the driver functioned as intended, and there was no evidence of a device malfunction.Despite the customer-reported fault alarm, risk to the patient was low because the driver continued to perform its life-sustaining functions.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.
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