There does not appear to be a temporal relationship between the liberty select cycler and the patient¿s hospitalization for unknown reason.The patient reportedly was completing pd therapy via manual exchanges prior to hospitalization due to the patient¿s previous cycler being processed for replacement after experiencing alarms during set-up of ccpd treatment.Based on the lack of sufficient information, it cannot be determined if the liberty select cycler may have caused on contributed to the patient¿s hospitalization the actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.
|